A Study of Pembrolizumab (MK-3475) in Combination With Chemotherapy or Immunotherapy in Participants With Non-small Cell Lung Cancer (MK-3475-021/KEYNOTE-021)

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ClinicalTrials.gov Identifier: NCT02039674

Recruitment Status : Completed

First Posted : January 17, 2014

Results First Posted : December 2, 2017

Last Update Posted : November 8, 2022

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Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme LLC

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Non-small Cell Lung Carcinoma
Interventions	Biological: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin Biological: Bevacizumab Drug: Pemetrexed Biological: Ipilimumab Drug: Erlotinib Drug: Gefitinib
Enrollment	267

Participant Flow

Recruitment Details	This results disclosure is based on efficacy data cutoff dates of 08-Aug-2016 for Cohorts C and G (primary endpoint); 07-Nov-2016 for Cohorts A, B, D, E, F and H; and 19-Aug-2019 for Cohort G (secondary endpoints).
Pre-assignment Details


Arm/Group Title	Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])	Part1 Cohort A10 (Pembro10mg/kg+Pa+C)	Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)	Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)	Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)	Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])	Part 1 Cohort D2 (Pembro 10 mg/kg+I)	Part 1 Cohort D4 (Pembro 2 mg/kg+I)	Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)	Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)	Part 2 Cohort H (Pembro 2mg/kg+I)
Arm/Group Description	Cohort A2 participants received pem...	Cohort A10 participants received pe...	Cohort B2 participants received pem...	Cohort B10 participants received pe...	Cohort C2 participants received pem...	Cohort C10 participants received pe...	Cohort D1 participants received pem...	Cohort D2 participants received pem...	Cohort D4 participants received pem...	Cohort E participants received pemb...	Cohort F participants received pemb...	Cohort G+ participants received pem...	Cohort G- participants received pla...	Cohort H participants received pemb...
Arm/Group Description	Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin AUC 5 (C 5 mg/mL/min) via IV infusion on Day 1 of each 3-week cycle.	Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
Period Title: Overall Study
Started	13	12	12	13	12	12	3	3	12	12	7	60	63	33
Treated	13	12	11	13	12	12	3	3	12	12	7	59	62	33
Received Second Course of Pembrolizumab	2	0	0	1	0	0	0	0	0	1	0	2	0	0
Switched Over to Pembrolizumab	0	0	0	0	0	0	0	0	0	0	0	0	28	0
Completed	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Not Completed	13	12	12	13	12	12	3	3	12	12	7	60	63	33
Reason Not Completed
Adverse Event	0	0	0	1	0	0	0	0	2	1	0	2	3	1
Death	2	0	2	3	0	0	1	0	2	0	1	3	2	8
Excluded Medication	1	1	0	1	0	1	0	0	2	3	5	6	8	3
Lost to Follow-up	0	0	0	0	1	1	0	0	0	0	0	2	2	1
Physician Decision	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Progressive Disease	8	8	6	7	9	10	1	3	6	4	0	34	34	18
Withdrawal by Subject	1	2	3	0	1	0	0	0	0	1	1	4	6	2
Clinical Progression	0	0	0	0	0	0	1	0	0	0	0	0	1	0
Sponsor Decision	1	1	1	1	1	0	0	0	0	3	0	8	5	0
Other	0	0	0	0	0	0	0	0	0	0	0	0	1	0

Baseline Characteristics

Arm/Group Title		Part1CohortA2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])	Part1CohortA10 (Pembro10mg/kg+Pa+C)	Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)	Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)	Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)	Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])	Part 1 Cohort D2 (Pembro 10 mg/kg+I)	Part 1 Cohort D4 (Pembro 2 mg/kg+I)	Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)	Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)	Part 2 Cohort H (Pembro 2 mg/kg+I)	Total
Arm/Group Description		Cohort A2 participants received pem...	Cohort A10 participants received pe...	Cohort B2 participants received pem...	Cohort B10 participants received pe...	Cohort C2 participants received pem...	Cohort C10 participants received pe...	Cohort D1 participants received pem...	Cohort D2 participants received pem...	Cohort D4 participants received pem...	Cohort E participants received pemb...	Cohort F participants received pemb...	Cohort G+ participants received pem...	Cohort G- participants received pla...	Cohort H participants received pemb...	Total of all reporting groups
Arm/Group Description		Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).	Total of all reporting groups
Overall Number of Baseline Participants		13	12	12	13	12	12	3	3	12	12	7	60	63	33	267
Baseline Analysis Population Description		...
Baseline Analysis Population Description		For Cohorts A, B, C and G, the analysis population consisted of all randomized participants. For Cohorts D, E, F and H, the analysis population consisted of all treated participants.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	13 participants	12 participants	12 participants	13 participants	12 participants	12 participants	3 participants	3 participants	12 participants	12 participants	7 participants	60 participants	63 participants	33 participants	267 participants
		64.5 (8.0)	61.4 (9.2)	61.2 (5.1)	59.5 (9.1)	60.3 (11.0)	63.3 (8.4)	69.3 (6.0)	59.3 (5.5)	55.3 (14.0)	60.2 (8.0)	62.7 (12.0)	61.8 (9.2)	63.2 (9.6)	62.2 (9.7)	61.8 (9.5)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	13 participants	12 participants	12 participants	13 participants	12 participants	12 participants	3 participants	3 participants	12 participants	12 participants	7 participants	60 participants	63 participants	33 participants	267 participants
	Female	5 38.5%	8 66.7%	6 50.0%	6 46.2%	6 50.0%	6 50.0%	2 66.7%	1 33.3%	4 33.3%	6 50.0%	4 57.1%	38 63.3%	37 58.7%	18 54.5%	147 55.1%
	Male	8 61.5%	4 33.3%	6 50.0%	7 53.8%	6 50.0%	6 50.0%	1 33.3%	2 66.7%	8 66.7%	6 50.0%	3 42.9%	22 36.7%	26 41.3%	15 45.5%	120 44.9%

Outcome Measures

1.Primary Outcome


Title	Part 2 Cohorts G+ and G-: Objective Response Rate (ORR)
Description	ORR was defined as the percentage of participants in the analysis popu...
Description	ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per Response Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by blinded independent central review (BICR).
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all randomized Cohort G participants (database cutoff date: 08 August 2016).


Arm/Group Title	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)
Arm/Group Description:	Cohort G+ participants received pem...	Cohort G- participants received pla...
Arm/Group Description:	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Overall Number of Participants Analyzed	60	63
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	55.0 (41.6 to 67.9)	28.6 (17.9 to 41.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 2 Cohort G+ (Pembro 200 mg+Pe+C), Part 2 Cohort G- (Placebo+Pe+C)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0016
	Comments	[Not Specified]
	Method	Miettinen & Nurminen Method
	Comments	[Not Specified]

Method of Estimation	Estimation Parameter	Difference in Percentages
	Estimated Value	26.3
	Confidence Interval	(2-Sided) 95% 8.9 to 42.1
	Estimation Comments	[Not Specified]

2.Primary Outcome


Title	Part 2 Cohorts D4 and H: Objective Response Rate (ORR)
Description	For participants who demonstrated a confirmed response (Complete Respo...
Description	For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all treated Cohort D4 and Cohort H participants (database cutoff date: 07 November 2016). One Cohort H participant was excluded from the efficacy analysis population due to a protocol violation. This participant did not have non-small cell lung cancer.


Arm/Group Title	Part 2 Cohorts D4 & H (Pembro 2mg/kg+I)
Arm/Group Description:	Cohort D4 and Cohort H participants...
Arm/Group Description:	Cohort D4 and Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
Overall Number of Participants Analyzed	44
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	29.5 (16.8 to 45.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 2 Cohorts D4 & H (Pembro 2mg/kg+I)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0858
	Comments	[Not Specified]
	Method	Exact binomial distribution for testing
	Comments	HO: ORR ≤20% versus H1: ORR >20%

3.Primary Outcome


Title	All Cohorts: Number of Participants Who Experienced a Dose-limiting Toxicity (DLT)
Description	DLTs were assessed using the National Cancer Institute Common Terminol...
Description	DLTs were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4. A DLT was defined as any of the following events: Grade 4 non-hematologic toxicity (not laboratory); Grade 4 hematologic toxicity lasting ≥7 days; Grade 3 non-hematologic toxicity (not laboratory, specifically nausea, vomiting and diarrhea) lasting >3 days despite optimal supportive care; Any Grade 3 or Grade 4 non-hematologic laboratory value requiring treatment or hospitalization, or persisting for >1 week; Febrile neutropenia Grade 3 or Grade 4; Qualifying thrombocytopenia <25,000/mm^3; Prolonged delay (>2 weeks) in initiating Cycle 2 due to treatment-related toxicity; Missing >10% of erlotinib or gefitinib doses as a result of adverse events (AEs) during the DLT window of observation; or Grade 5 toxicity.
Time Frame	Cycle 1 (Up to 21 days)

Outcome Measure Data

Analysis Population Description

The DLT evaluable population consisted of all participants who completed the first cycle of study treatment or who discontinued from the study due to a drug-related AE.


Arm/Group Title	Part1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])	Part1 Cohort A10 (Pembro10mg/kg+Pa+C)	Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])	Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)	Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)	Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)	Part 1 Cohort D1 (Pembro 10mg/kg+Ipilimumab [I])	Part 1 Cohort D2 (Pembro 10 mg/kg+I)	Part 1 Cohort D4 (Pembro 2 mg/kg+I)	Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)	Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)	Part 2 Cohort H (Pembro 2 mg/kg+I)
Arm/Group Description:	Cohort A2 participants received pem...	Cohort A10 participants received pe...	Cohort B2 participants received pem...	Cohort B10 participants received pe...	Cohort C2 participants received pem...	Cohort C10 participants received pe...	Cohort D1 participants received pem...	Cohort D2 participants received pem...	Cohort D4 participants received pem...	Cohort E participants received pemb...	Cohort F participants received pemb...	Cohort G+ participants received pem...	Cohort G- participants received pla...	Cohort H participants received pemb...
Arm/Group Description:	Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via intravenous (IV) infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C Area Under the Curve [AUC] 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.	Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.	Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
Overall Number of Participants Analyzed	13	12	11	13	12	12	3	3	12	12	7	59	62	33
Measure Type: Count of Participants Unit of Measure: Participants
	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

4.Secondary Outcome


Title	Part 2 Cohorts G+ and G-: Progression-Free Survival (PFS)
Description	PFS was defined as the time from randomization to the first documented...
Description	PFS was defined as the time from randomization to the first documented disease progression, or death due to any cause, whichever occurred first. Per RECIST 1.1, progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. PFS was assessed by BICR.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).


Arm/Group Title	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)
Arm/Group Description:	Cohort G+ participants received pem...	Cohort G- participants received pla...
Arm/Group Description:	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Overall Number of Participants Analyzed	60	63
Median (95% Confidence Interval) Unit of Measure: Months
	24.5 (9.7 to 36.3)	9.9 (6.2 to 15.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 2 Cohort G+ (Pembro 200 mg+Pe+C), Part 2 Cohort G- (Placebo+Pe+C)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.00252
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on log-rank test

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.54
	Confidence Interval	(2-Sided) 95% 0.35 to 0.83
	Estimation Comments	[Not Specified]

5.Secondary Outcome


Title	Part 2 Cohorts G+ and G-: Overall Survival (OS)
Description	OS was defined as the time from randomization to death due to any caus...
Description	OS was defined as the time from randomization to death due to any cause.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all randomized Cohort G participants (database cutoff date: 19 August 2019).


Arm/Group Title	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)
Arm/Group Description:	Cohort G+ participants received pem...	Cohort G- participants received pla...
Arm/Group Description:	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Overall Number of Participants Analyzed	60	63
Median (95% Confidence Interval) Unit of Measure: Months
	34.5 ^[1] (24.0 to NA)	21.1 (14.9 to 35.6)

[1]

NA=Upper limit of OS not reached.

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Part 2 Cohort G+ (Pembro 200 mg+Pe+C), Part 2 Cohort G- (Placebo+Pe+C)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.06762
	Comments	[Not Specified]
	Method	Log Rank
	Comments	One-sided p-value based on log-rank test

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.71
	Confidence Interval	(2-Sided) 95% 0.45 to 1.12
	Estimation Comments	[Not Specified]

6.Secondary Outcome


Title	Part 2 Cohorts G+ and G-: Duration of Response (DOR)
Description	For participants who demonstrated a confirmed response (Complete Respo...
Description	For participants who demonstrated a confirmed response (Complete Response [CR]: Disappearance of all target lesions or Partial Response [PR]: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. Per RECIST 1.1, DOR was defined as the time from first documented evidence of CR or PR until disease progression or death. DOR was assessed by BICR.
Time Frame	Up to approximately 2 years

Outcome Measure Data

Analysis Population Description

The analysis population consisted of all randomized Cohort G participants who experienced a confirmed response (CR or PR); (database cutoff date: 19 August 2019).


Arm/Group Title	Part 2 Cohort G+ (Pembro 200 mg+Pe+C)	Part 2 Cohort G- (Placebo+Pe+C)
Arm/Group Description:	Cohort G+ participants received pem...	Cohort G- participants received pla...
Arm/Group Description:	Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.	Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.
Overall Number of Participants Analyzed	35	21
Median (Full Range) Unit of Measure: Months
	NA ^[1] (NA to NA)	NA ^[1] (NA to NA)

[1]

NA=DOR median not reached at time of data cut-off due to insufficient number of responding participants with relapse.

NA=DOR lower and upper limits not reached at time of data cut-off due to insufficient number of responding participants with relapse.

Adverse Events

Time Frame	Up to approximately 92 months (Up to 90 days after last dose of study treatment)
Adverse Event Reporting Description	Safety Population: All treated participants. All-Cause Mortality Population: All randomized participants. Per protocol, disease progression of cancer under study was not considered an adverse event (AE) unless considered related to study treatment. Thus, Medical Dictionary for Regulatory Activities (MedDRA) preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study treatment are excluded as AEs.

Arm/Group Title	Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)		Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])		Cohort A Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)		Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])		Cohort B Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)		Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)		Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])		Part 1 Cohort D2 (Pembro 10 mg/kg+I)		Part 1 Cohort D4 (Pembro 2 mg/kg+I)		Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)		Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)		Cohort E Second Course (Pembro 2 mg/kg Monotherapy)		Part 2 Cohort G+ (Pembro 200 mg+Pe+C)		Part 2 Cohort G- (Placebo+Pe+C)		Cohort G+ Second Course (Pembro 200 mg Monotherapy)		Cohort G Crossover (Pembro 200 mg Monotherapy)		Part 2 Cohort H (Pembro 2mg/kg+I)
Arm/Group Description	Cohort A10 participants received pe...		Cohort A2 participants received pem...		Cohort A Second Course participants...		Cohort B10 participants received pe...		Cohort B2 participants received pem...		Cohort B Second Course participants...		Cohort C10 participants received pe...		Cohort C2 participants received pem...		Cohort D1 participants received pem...		Cohort D2 participants received pem...		Cohort D4 participants received pem...		Cohort E participants received pemb...		Cohort F participants received pemb...		Cohort E Second Course participants...		Cohort G+ participants received pem...		Cohort G- participants received pla...		Cohort G+ Second Course participant...		Cohort G Crossover participants rec...		Cohort H participants received pemb...
Arm/Group Description	Cohort A10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.		Cohort A2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.		Cohort A Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort B10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2 via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort B2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS paclitaxel (Pa 200 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS bevacizumab (B 15 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort B Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort C10 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 6 [6 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.		Cohort C2 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.		Cohort D1 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort D2 participants received pembrolizumab (Pembro 10 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 3 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort D4 participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS iIpilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort E participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS erlotinib (E 150 mg) via oral tablet once a day on every day of each 3-week cycle.		Cohort F participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS gefitinib (G 250 mg) via oral tablet once a day on every day of each 3-week cycle.		Cohort E Second Course participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle.		Cohort G+ participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle.		Cohort G- participants received placebo (normal saline solution) via IV infusion on Day 1 of each 3-week cycle PLUS pemetrexed (Pe 500 mg/m^2) via IV infusion on Day 1 of each 3-week cycle PLUS carboplatin (C AUC 5 [5 mg/mL/min]) via IV infusion on Day 1 of each 3-week cycle.		Cohort G+ Second Course participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.		Cohort G Crossover participants received pembrolizumab (Pembro 200 mg) via IV infusion on Day 1 of each 3-week cycle.		Cohort H participants received pembrolizumab (Pembro 2 mg/kg) via IV infusion on Day 1 of each 3-week cycle PLUS ipilimumab (I 1 mg/kg) via IV infusion on Day 1 of each 3-week cycle (at the recommended Phase 2 dose determined in Cohort D).
All-Cause Mortality
	Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)		Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])		Cohort A Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)		Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])		Cohort B Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)		Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)		Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])		Part 1 Cohort D2 (Pembro 10 mg/kg+I)		Part 1 Cohort D4 (Pembro 2 mg/kg+I)		Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)		Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)		Cohort E Second Course (Pembro 2 mg/kg Monotherapy)		Part 2 Cohort G+ (Pembro 200 mg+Pe+C)		Part 2 Cohort G- (Placebo+Pe+C)		Cohort G+ Second Course (Pembro 200 mg Monotherapy)		Cohort G Crossover (Pembro 200 mg Monotherapy)		Part 2 Cohort H (Pembro 2mg/kg+I)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	10/12 (83.33%)		10/13 (76.92%)		2/2 (100.00%)		11/13 (84.62%)		9/12 (75.00%)		1/1 (100.00%)		11/12 (91.67%)		8/12 (66.67%)		3/3 (100.00%)		3/3 (100.00%)		11/12 (91.67%)		5/12 (41.67%)		7/7 (100.00%)		0/1 (0.00%)		42/60 (70.00%)		47/63 (74.60%)		1/2 (50.00%)		24/28 (85.71%)		31/33 (93.94%)
Serious Adverse Events Serious Adverse Events
	Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)		Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])		Cohort A Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)		Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])		Cohort B Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)		Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)		Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])		Part 1 Cohort D2 (Pembro 10 mg/kg+I)		Part 1 Cohort D4 (Pembro 2 mg/kg+I)		Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)		Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)		Cohort E Second Course (Pembro 2 mg/kg Monotherapy)		Part 2 Cohort G+ (Pembro 200 mg+Pe+C)		Part 2 Cohort G- (Placebo+Pe+C)		Cohort G+ Second Course (Pembro 200 mg Monotherapy)		Cohort G Crossover (Pembro 200 mg Monotherapy)		Part 2 Cohort H (Pembro 2mg/kg+I)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/12 (41.67%)		7/13 (53.85%)		0/2 (0.00%)		8/13 (61.54%)		8/11 (72.73%)		0/1 (0.00%)		7/12 (58.33%)		6/12 (50.00%)		1/3 (33.33%)		1/3 (33.33%)		5/12 (41.67%)		8/12 (66.67%)		5/7 (71.43%)		0/1 (0.00%)		30/59 (50.85%)		21/62 (33.87%)		0/2 (0.00%)		7/28 (25.00%)		12/33 (36.36%)
Blood and lymphatic system disorders
Anaemia ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Febrile neutropenia ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	3	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neutropenia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pancytopenia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Thrombocytopenia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cardiac disorders
Aortic valve disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Arteriosclerosis coronary artery ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Atrial fibrillation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cardiac failure congestive ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Cardiac tamponade ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cardiac ventricular thrombosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cardiogenic shock ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Coronary artery disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Myocardial infarction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Myocarditis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pericardial effusion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Tachycardia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Endocrine disorders
Adrenal insufficiency ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypothyroidism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Gastrointestinal disorders
Abdominal pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Autoimmune colitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Colitis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	2
Constipation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Diarrhoea ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diarrhoea haemorrhagic ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diverticular perforation ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Dysphagia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haematochezia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Intestinal perforation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Large intestine perforation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Nausea ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Oesophagitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Pancreatitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Peptic ulcer ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Retroperitoneal haematoma ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Salivary gland calculus ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Small intestinal obstruction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vomiting ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
General disorders
Asthenia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Death ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Fatigue ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Non-cardiac chest pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pyrexia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	3/12 (25.00%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hepatobiliary disorders
Hepatic function abnormal ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hepatocellular injury ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Immune system disorders
Anaphylactic reaction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Drug hypersensitivity ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypersensitivity ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Infections and infestations
Bacteraemia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cellulitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	5	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diverticulitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gastroenteritis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Infectious pleural effusion ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Influenza ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Periorbital cellulitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Peritonitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Pneumonia ^† 1	2/12 (16.67%)	2	3/13 (23.08%)	3	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	5	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Pneumonia aspiration ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pyelonephritis acute ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Respiratory syncytial virus infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Sepsis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Septic shock ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Upper respiratory tract infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urinary tract infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urosepsis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Injury, poisoning and procedural complications
Femur fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hip fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Radiation oesophagitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Spinal fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	5/7 (71.43%)	5	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Aspartate aminotransferase increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	5/7 (71.43%)	5	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Blood pressure increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Liver function test increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Transaminases increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Troponin increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
White blood cell count decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Metabolism and nutrition disorders
Dehydration ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diabetic ketoacidosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Hypokalaemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Back pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Flank pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neck pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Small cell lung cancer ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Squamous cell carcinoma of skin ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Nervous system disorders
Cerebrovascular accident ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cerebrovascular disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Encephalopathy ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haemorrhage intracranial ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Headache ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neuralgic amyotrophy ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Syncope ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Transient ischaemic attack ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Psychiatric disorders
Depression ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Mental status changes ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	5	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Chronic kidney disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Dyspnoea ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	2	0/33 (0.00%)	0
Haemoptysis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypoxia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Lung infiltration ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pleural effusion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pneumonitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Pneumothorax ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pulmonary embolism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin and subcutaneous tissue disorders
Drug eruption ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash maculo-papular ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urticaria ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vascular disorders
Aortic stenosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Deep vein thrombosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Embolism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypertension ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Part 1 Cohort A10 (Pembro10mg/kg+Pa+C)		Part 1 Cohort A2 (Pembro 2 mg/kg+Paclitaxel [Pa]+Carboplatin [C])		Cohort A Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort B10 (Pembro 10 mg/kg+Pa+C+B)		Part 1 Cohort B2 (Pembro 2mg/kg+Pa+C+Bevacizumab [B])		Cohort B Second Course (Pembro 2 mg/kg Monotherapy)		Part 1 Cohort C10 (Pembro 10 mg/kg+Pe+C)		Part 1 Cohort C2 (Pembro 2 mg/kg+Pemetrexed [Pe]+C)		Part 1 Cohort D1 (Pembro 10 mg/kg+Ipilimumab [I])		Part 1 Cohort D2 (Pembro 10 mg/kg+I)		Part 1 Cohort D4 (Pembro 2 mg/kg+I)		Part 1 Cohort E (Pembro 2 mg/kg+Erlotinib)		Part 1 Cohort F (Pembro 2 mg/kg+Gefitinib)		Cohort E Second Course (Pembro 2 mg/kg Monotherapy)		Part 2 Cohort G+ (Pembro 200 mg+Pe+C)		Part 2 Cohort G- (Placebo+Pe+C)		Cohort G+ Second Course (Pembro 200 mg Monotherapy)		Cohort G Crossover (Pembro 200 mg Monotherapy)		Part 2 Cohort H (Pembro 2mg/kg+I)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/12 (100.00%)		13/13 (100.00%)		0/2 (0.00%)		12/13 (92.31%)		11/11 (100.00%)		0/1 (0.00%)		12/12 (100.00%)		12/12 (100.00%)		3/3 (100.00%)		3/3 (100.00%)		12/12 (100.00%)		12/12 (100.00%)		7/7 (100.00%)		1/1 (100.00%)		58/59 (98.31%)		60/62 (96.77%)		0/2 (0.00%)		24/28 (85.71%)		30/33 (90.91%)
Blood and lymphatic system disorders
Anaemia ^† 1	4/12 (33.33%)	4	5/13 (38.46%)	7	0/2 (0.00%)	0	5/13 (38.46%)	5	2/11 (18.18%)	2	0/1 (0.00%)	0	6/12 (50.00%)	7	3/12 (25.00%)	3	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	21/59 (35.59%)	33	36/62 (58.06%)	41	0/2 (0.00%)	0	3/28 (10.71%)	4	0/33 (0.00%)	0
Febrile neutropenia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Increased tendency to bruise ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Leukopenia ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neutropenia ^† 1	1/12 (8.33%)	1	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	6	7/62 (11.29%)	9	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Thrombocytopenia ^† 1	4/12 (33.33%)	5	1/13 (7.69%)	1	0/2 (0.00%)	0	2/13 (15.38%)	3	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	6	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Lymphadenopathy ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cardiac disorders
Atrial fibrillation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Atrioventricular block second degree ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diastolic dysfunction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Left ventricular failure ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Myocardial infarction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Palpitations ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Sinus tachycardia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Tachycardia ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Cardiac ventricular thrombosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Ear and labyrinth disorders
Deafness ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Ear pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypoacusis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Tinnitus ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vertigo ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	6	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Endocrine disorders
Adrenal insufficiency ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cushingoid ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hyperparathyroidism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hyperthyroidism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	7	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Hypogonadism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypothyroidism ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	3	0/2 (0.00%)	0	1/13 (7.69%)	2	4/11 (36.36%)	4	0/1 (0.00%)	0	2/12 (16.67%)	2	2/12 (16.67%)	2	1/3 (33.33%)	1	0/3 (0.00%)	0	2/12 (16.67%)	2	4/12 (33.33%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	9/59 (15.25%)	9	2/62 (3.23%)	2	0/2 (0.00%)	0	5/28 (17.86%)	5	8/33 (24.24%)	8
Thyroiditis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Autoimmune thyroiditis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eye disorders
Asthenopia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blepharitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cataract ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Corneal erosion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cystoid macular oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dry eye ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	3/12 (25.00%)	3	1/7 (14.29%)	1	0/1 (0.00%)	0	10/59 (16.95%)	10	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Eye discharge ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eye disorder ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eye irritation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Eye pruritus ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eyelid disorder ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eyelid rash ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Glaucoma ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Iritis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Lacrimation increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	3	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	10/59 (16.95%)	14	9/62 (14.52%)	10	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Periorbital oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Uveitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vision blurred ^† 1	2/12 (16.67%)	2	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	5	5/62 (8.06%)	5	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Visual impairment ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Vitreous floaters ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Gastrointestinal disorders
Abdominal discomfort ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Abdominal distension ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	3/59 (5.08%)	4	5/62 (8.06%)	5	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Abdominal pain ^† 1	3/12 (25.00%)	3	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	3/12 (25.00%)	3	0/12 (0.00%)	0	0/7 (0.00%)	0	1/1 (100.00%)	1	8/59 (13.56%)	11	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Abdominal pain upper ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	6/59 (10.17%)	6	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Anal haemorrhage ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Anorectal discomfort ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Ascites ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Chapped lips ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cheilitis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Colitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	2
Constipation ^† 1	7/12 (58.33%)	7	8/13 (61.54%)	9	0/2 (0.00%)	0	5/13 (38.46%)	6	9/11 (81.82%)	9	0/1 (0.00%)	0	7/12 (58.33%)	9	8/12 (66.67%)	8	0/3 (0.00%)	0	1/3 (33.33%)	1	5/12 (41.67%)	5	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	32/59 (54.24%)	41	25/62 (40.32%)	30	0/2 (0.00%)	0	3/28 (10.71%)	3	9/33 (27.27%)	10
Dental caries ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diarrhoea ^† 1	2/12 (16.67%)	6	4/13 (30.77%)	7	0/2 (0.00%)	0	5/13 (38.46%)	8	3/11 (27.27%)	4	0/1 (0.00%)	0	4/12 (33.33%)	5	4/12 (33.33%)	4	1/3 (33.33%)	1	2/3 (66.67%)	2	2/12 (16.67%)	3	8/12 (66.67%)	11	4/7 (57.14%)	5	0/1 (0.00%)	0	26/59 (44.07%)	39	19/62 (30.65%)	32	0/2 (0.00%)	0	6/28 (21.43%)	10	6/33 (18.18%)	8
Dry mouth ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	7	4/62 (6.45%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Dyspepsia ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	8/59 (13.56%)	14	2/62 (3.23%)	3	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Dysphagia ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	5/62 (8.06%)	5	0/2 (0.00%)	0	2/28 (7.14%)	2	2/33 (6.06%)	2
Enterocolitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Flatulence ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gastric ulcer ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gastritis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Gastrooesophageal reflux disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/3 (0.00%)	0	1/3 (33.33%)	1	1/12 (8.33%)	1	2/12 (16.67%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	5/59 (8.47%)	7	2/62 (3.23%)	2	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Gingival bleeding ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gingival pain ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haematemesis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haematochezia ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haemorrhoids ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Lip disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Mouth ulceration ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nausea ^† 1	4/12 (33.33%)	5	7/13 (53.85%)	11	0/2 (0.00%)	0	6/13 (46.15%)	7	7/11 (63.64%)	8	0/1 (0.00%)	0	5/12 (41.67%)	5	7/12 (58.33%)	8	0/3 (0.00%)	0	0/3 (0.00%)	0	4/12 (33.33%)	6	3/12 (25.00%)	3	1/7 (14.29%)	1	0/1 (0.00%)	0	43/59 (72.88%)	88	37/62 (59.68%)	51	0/2 (0.00%)	0	6/28 (21.43%)	12	7/33 (21.21%)	9
Odynophagia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Oral dysaesthesia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Oral pain ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	3/33 (9.09%)	3
Oral papule ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Proctalgia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rectal polyp ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rectal ulcer ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Stomatitis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	3/13 (23.08%)	3	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	5	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	16	6/62 (9.68%)	10	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Tongue erythema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Toothache ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	3
Vomiting ^† 1	2/12 (16.67%)	3	1/13 (7.69%)	2	0/2 (0.00%)	0	2/13 (15.38%)	3	4/11 (36.36%)	4	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	1/3 (33.33%)	1	1/3 (33.33%)	2	5/12 (41.67%)	7	2/12 (16.67%)	4	1/7 (14.29%)	1	0/1 (0.00%)	0	28/59 (47.46%)	59	20/62 (32.26%)	25	0/2 (0.00%)	0	5/28 (17.86%)	6	8/33 (24.24%)	9
General disorders
Asthenia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	1/59 (1.69%)	1	4/62 (6.45%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Catheter site pain ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Chest discomfort ^† 1	1/12 (8.33%)	1	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Chest pain ^† 1	0/12 (0.00%)	0	3/13 (23.08%)	5	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	5/62 (8.06%)	5	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Chills ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/3 (0.00%)	0	2/3 (66.67%)	2	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	5	3/62 (4.84%)	3	0/2 (0.00%)	0	3/28 (10.71%)	7	0/33 (0.00%)	0
Exercise tolerance decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Face oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	3/12 (25.00%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Facial pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Fatigue ^† 1	8/12 (66.67%)	8	8/13 (61.54%)	12	0/2 (0.00%)	0	5/13 (38.46%)	5	8/11 (72.73%)	8	0/1 (0.00%)	0	11/12 (91.67%)	11	6/12 (50.00%)	6	3/3 (100.00%)	3	2/3 (66.67%)	2	4/12 (33.33%)	5	7/12 (58.33%)	7	0/7 (0.00%)	0	0/1 (0.00%)	0	41/59 (69.49%)	73	36/62 (58.06%)	42	0/2 (0.00%)	0	7/28 (25.00%)	7	16/33 (48.48%)	21
Feeling cold ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gait disturbance ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Generalised oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Influenza like illness ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	1/1 (100.00%)	1	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Infusion site phlebitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Localised oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Malaise ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	4/59 (6.78%)	4	2/62 (3.23%)	5	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Mucosal inflammation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	7	1/62 (1.61%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Non-cardiac chest pain ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	6	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Oedema ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	5	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Oedema peripheral ^† 1	0/12 (0.00%)	0	4/13 (30.77%)	6	0/2 (0.00%)	0	2/13 (15.38%)	3	0/11 (0.00%)	0	0/1 (0.00%)	0	3/12 (25.00%)	5	3/12 (25.00%)	5	0/3 (0.00%)	0	1/3 (33.33%)	1	1/12 (8.33%)	1	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	16/59 (27.12%)	22	15/62 (24.19%)	19	0/2 (0.00%)	0	2/28 (7.14%)	2	2/33 (6.06%)	2
Pain ^† 1	3/12 (25.00%)	3	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	4/62 (6.45%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Peripheral swelling ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pyrexia ^† 1	0/12 (0.00%)	0	4/13 (30.77%)	6	0/2 (0.00%)	0	3/13 (23.08%)	4	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	1/12 (8.33%)	1	5/12 (41.67%)	7	1/7 (14.29%)	1	0/1 (0.00%)	0	7/59 (11.86%)	11	4/62 (6.45%)	5	0/2 (0.00%)	0	5/28 (17.86%)	8	3/33 (9.09%)	3
Swelling ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Temperature intolerance ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Xerosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hepatobiliary disorders
Autoimmune hepatitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Jaundice ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Immune system disorders
Drug hypersensitivity ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypersensitivity ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Seasonal allergy ^† 1	1/12 (8.33%)	1	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Infections and infestations
Abscess limb ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Bacteraemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Bronchitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	3/12 (25.00%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	6	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Candida infection ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Cellulitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	12	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Conjunctivitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	6/59 (10.17%)	10	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cystitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cystitis escherichia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Diverticulitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Eye infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Folliculitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Fungal infection ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Fungal skin infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Furuncle ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gastroenteritis viral ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Giardiasis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gingival abscess ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Herpes zoster ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	2/59 (3.39%)	2	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Hordeolum ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Influenza ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Laryngitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Mucosal infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Nasopharyngitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Oral candidiasis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Oral herpes ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Otitis media ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Paronychia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Periodontitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pharyngitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pneumonia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	1/62 (1.61%)	1	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Pneumonia bacterial ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pustule ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash pustular ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Respiratory tract infection ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Respiratory tract infection viral ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rhinitis ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	6/62 (9.68%)	7	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Sinusitis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	8/59 (13.56%)	9	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Skin bacterial infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Tooth infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Upper respiratory tract infection ^† 1	1/12 (8.33%)	2	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	3/11 (27.27%)	5	0/1 (0.00%)	0	3/12 (25.00%)	5	3/12 (25.00%)	4	0/3 (0.00%)	0	0/3 (0.00%)	0	2/12 (16.67%)	2	4/12 (33.33%)	11	1/7 (14.29%)	1	0/1 (0.00%)	0	14/59 (23.73%)	23	5/62 (8.06%)	8	0/2 (0.00%)	0	3/28 (10.71%)	3	1/33 (3.03%)	1
Urinary tract infection ^† 1	2/12 (16.67%)	2	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	3/12 (25.00%)	4	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	12/59 (20.34%)	14	3/62 (4.84%)	5	0/2 (0.00%)	0	4/28 (14.29%)	5	3/33 (9.09%)	3
Viral infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vulvovaginal mycotic infection ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Injury, poisoning and procedural complications
Contusion ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Fall ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	10/59 (16.95%)	15	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	3/33 (9.09%)	3
Foot fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin abrasion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Skin laceration ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Tooth fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Wound ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Arthropod bite ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Radius fracture ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Investigations
Alanine aminotransferase increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	4/12 (33.33%)	5	4/12 (33.33%)	8	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	4/12 (33.33%)	6	0/7 (0.00%)	0	0/1 (0.00%)	0	11/59 (18.64%)	17	12/62 (19.35%)	17	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Aspartate aminotransferase increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	2/13 (15.38%)	3	0/11 (0.00%)	0	0/1 (0.00%)	0	3/12 (25.00%)	5	3/12 (25.00%)	7	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	4/12 (33.33%)	6	0/7 (0.00%)	0	0/1 (0.00%)	0	12/59 (20.34%)	19	15/62 (24.19%)	20	0/2 (0.00%)	0	2/28 (7.14%)	3	1/33 (3.03%)	1
Bilirubin conjugated increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood alkaline phosphatase increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	5	7/62 (11.29%)	9	0/2 (0.00%)	0	1/28 (3.57%)	2	2/33 (6.06%)	2
Blood bilirubin increased ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Blood cholesterol increased ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood creatinine increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	2/11 (18.18%)	4	0/1 (0.00%)	0	4/12 (33.33%)	4	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	15/59 (25.42%)	19	7/62 (11.29%)	11	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Blood glucose increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Blood magnesium decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood phosphorus decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood potassium increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood thyroid stimulating hormone decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Blood thyroid stimulating hormone increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Blood urea increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Electrocardiogram QT prolonged ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Glycosylated haemoglobin increased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haemoglobin decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Lymphocyte count decreased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	2	1/3 (33.33%)	1	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	8	3/62 (4.84%)	5	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Neutrophil count decreased ^† 1	2/12 (16.67%)	2	1/13 (7.69%)	1	0/2 (0.00%)	0	4/13 (30.77%)	5	3/11 (27.27%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	11/59 (18.64%)	14	8/62 (12.90%)	10	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Platelet count decreased ^† 1	1/12 (8.33%)	1	1/13 (7.69%)	1	0/2 (0.00%)	0	2/13 (15.38%)	3	3/11 (27.27%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	8/62 (12.90%)	11	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Thyroxine free increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Tri-iodothyronine decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Weight decreased ^† 1	2/12 (16.67%)	2	3/13 (23.08%)	3	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	3	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	8/59 (13.56%)	10	9/62 (14.52%)	9	0/2 (0.00%)	0	2/28 (7.14%)	2	5/33 (15.15%)	6
Weight increased ^† 1	1/12 (8.33%)	1	3/13 (23.08%)	3	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	7	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
White blood cell count decreased ^† 1	1/12 (8.33%)	1	2/13 (15.38%)	4	0/2 (0.00%)	0	4/13 (30.77%)	10	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	8	8/62 (12.90%)	13	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
White blood cells urine positive ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Thyroxine free decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Metabolism and nutrition disorders
Cachexia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Decreased appetite ^† 1	5/12 (41.67%)	5	7/13 (53.85%)	8	0/2 (0.00%)	0	7/13 (53.85%)	7	2/11 (18.18%)	2	0/1 (0.00%)	0	5/12 (41.67%)	7	3/12 (25.00%)	3	1/3 (33.33%)	1	2/3 (66.67%)	2	4/12 (33.33%)	5	2/12 (16.67%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	22/59 (37.29%)	29	17/62 (27.42%)	21	0/2 (0.00%)	0	9/28 (32.14%)	11	6/33 (18.18%)	6
Dehydration ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	0/3 (0.00%)	0	1/3 (33.33%)	1	3/12 (25.00%)	3	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	6	4/62 (6.45%)	4	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Glucose tolerance impaired ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Gout ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Hypercalcaemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	4/62 (6.45%)	4	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Hypercholesterolaemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hyperglycaemia ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	3/11 (27.27%)	3	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	12/59 (20.34%)	21	6/62 (9.68%)	9	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Hyperkalaemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypernatraemia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypertriglyceridaemia ^† 1	0/12 (0.00%)	0	3/13 (23.08%)	5	0/2 (0.00%)	0	2/13 (15.38%)	2	2/11 (18.18%)	2	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Hyperuricaemia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypoalbuminaemia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	2/12 (16.67%)	2	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	2/62 (3.23%)	4	0/2 (0.00%)	0	2/28 (7.14%)	3	2/33 (6.06%)	2
Hypocalcaemia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	3/13 (23.08%)	4	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	7	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Hypokalaemia ^† 1	1/12 (8.33%)	1	2/13 (15.38%)	3	0/2 (0.00%)	0	1/13 (7.69%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	4/12 (33.33%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	12/59 (20.34%)	17	8/62 (12.90%)	10	0/2 (0.00%)	0	0/28 (0.00%)	0	3/33 (9.09%)	3
Hypomagnesaemia ^† 1	1/12 (8.33%)	1	2/13 (15.38%)	2	0/2 (0.00%)	0	5/13 (38.46%)	5	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	2/12 (16.67%)	2	0/3 (0.00%)	0	1/3 (33.33%)	2	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	5	3/62 (4.84%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	3/33 (9.09%)	3
Hyponatraemia ^† 1	1/12 (8.33%)	1	3/13 (23.08%)	5	0/2 (0.00%)	0	4/13 (30.77%)	4	0/11 (0.00%)	0	0/1 (0.00%)	0	3/12 (25.00%)	3	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	4/62 (6.45%)	4	0/2 (0.00%)	0	3/28 (10.71%)	3	1/33 (3.03%)	2
Hypophosphataemia ^† 1	0/12 (0.00%)	0	3/13 (23.08%)	3	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	13	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	4/12 (33.33%)	4	6/13 (46.15%)	10	0/2 (0.00%)	0	5/13 (38.46%)	8	7/11 (63.64%)	8	0/1 (0.00%)	0	4/12 (33.33%)	6	4/12 (33.33%)	4	0/3 (0.00%)	0	2/3 (66.67%)	2	2/12 (16.67%)	3	4/12 (33.33%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	20/59 (33.90%)	32	18/62 (29.03%)	25	0/2 (0.00%)	0	4/28 (14.29%)	5	8/33 (24.24%)	8
Arthritis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Back pain ^† 1	3/12 (25.00%)	3	3/13 (23.08%)	3	0/2 (0.00%)	0	3/13 (23.08%)	3	3/11 (27.27%)	3	0/1 (0.00%)	0	1/12 (8.33%)	1	4/12 (33.33%)	4	1/3 (33.33%)	1	1/3 (33.33%)	1	3/12 (25.00%)	3	2/12 (16.67%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	12/59 (20.34%)	18	8/62 (12.90%)	9	0/2 (0.00%)	0	3/28 (10.71%)	3	3/33 (9.09%)	3
Bone pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Connective tissue disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Flank pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/7 (14.29%)	1	0/1 (0.00%)	0	1/59 (1.69%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Foot deformity ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Groin pain ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Joint range of motion decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Joint swelling ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Limb discomfort ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Mobility decreased ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Muscle spasms ^† 1	3/12 (25.00%)	4	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	3/12 (25.00%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	5	1/62 (1.61%)	1	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Muscular weakness ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Musculoskeletal chest pain ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	2/13 (15.38%)	3	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	6	4/62 (6.45%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Musculoskeletal discomfort ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Musculoskeletal pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Musculoskeletal stiffness ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	2	0/33 (0.00%)	0
Myalgia ^† 1	0/12 (0.00%)	0	3/13 (23.08%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	2/12 (16.67%)	2	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	9	3/62 (4.84%)	3	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Myalgia intercostal ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neck pain ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	5/62 (8.06%)	5	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Pain in extremity ^† 1	3/12 (25.00%)	5	3/13 (23.08%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	4/11 (36.36%)	5	0/1 (0.00%)	0	3/12 (25.00%)	3	2/12 (16.67%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	9/59 (15.25%)	10	5/62 (8.06%)	9	0/2 (0.00%)	0	0/28 (0.00%)	0	4/33 (12.12%)	4
Pain in jaw ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Periarthritis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Spinal osteoarthritis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Spinal stenosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Synovial cyst ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Tendonitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Ocular surface squamous neoplasia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nervous system disorders
Ageusia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Balance disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Carpal tunnel syndrome ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Cognitive disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	5	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Dizziness ^† 1	2/12 (16.67%)	2	2/13 (15.38%)	2	0/2 (0.00%)	0	1/13 (7.69%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	4/12 (33.33%)	4	3/12 (25.00%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	2/12 (16.67%)	2	6/12 (50.00%)	6	0/7 (0.00%)	0	1/1 (100.00%)	1	15/59 (25.42%)	19	12/62 (19.35%)	17	0/2 (0.00%)	0	3/28 (10.71%)	3	3/33 (9.09%)	3
Dizziness postural ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dysarthria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dysgeusia ^† 1	3/12 (25.00%)	4	3/13 (23.08%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	7	9/62 (14.52%)	9	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Head titubation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Headache ^† 1	1/12 (8.33%)	1	3/13 (23.08%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	4/11 (36.36%)	4	0/1 (0.00%)	0	1/12 (8.33%)	1	3/12 (25.00%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	4	1/7 (14.29%)	1	0/1 (0.00%)	0	20/59 (33.90%)	30	14/62 (22.58%)	14	0/2 (0.00%)	0	4/28 (14.29%)	5	6/33 (18.18%)	7
Hypoaesthesia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	3	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Hypogeusia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Memory impairment ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neuralgia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Neuropathy peripheral ^† 1	3/12 (25.00%)	3	5/13 (38.46%)	5	0/2 (0.00%)	0	3/13 (23.08%)	4	2/11 (18.18%)	2	0/1 (0.00%)	0	3/12 (25.00%)	4	3/12 (25.00%)	3	0/3 (0.00%)	0	1/3 (33.33%)	1	1/12 (8.33%)	1	4/12 (33.33%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	8/59 (13.56%)	9	4/62 (6.45%)	5	0/2 (0.00%)	0	0/28 (0.00%)	0	4/33 (12.12%)	4
Neurotoxicity ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Paraesthesia ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	3/11 (27.27%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Peripheral motor neuropathy ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Peripheral sensory neuropathy ^† 1	3/12 (25.00%)	3	3/13 (23.08%)	3	0/2 (0.00%)	0	3/13 (23.08%)	3	5/11 (45.45%)	5	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	4/62 (6.45%)	4	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Post herpetic neuralgia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Seizure ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Sinus headache ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Somnolence ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Syncope ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	6	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Taste disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	14	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Tremor ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Vocal cord paralysis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Myasthenia gravis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Psychiatric disorders
Anxiety ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	2	0/1 (0.00%)	0	1/12 (8.33%)	1	3/12 (25.00%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	7	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Confusional state ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Depressed mood ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Depression ^† 1	1/12 (8.33%)	1	3/13 (23.08%)	3	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	9/62 (14.52%)	9	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Emotional poverty ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Insomnia ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	3/13 (23.08%)	3	2/11 (18.18%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	15/59 (25.42%)	22	9/62 (14.52%)	11	0/2 (0.00%)	0	2/28 (7.14%)	2	3/33 (9.09%)	3
Irritability ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Libido decreased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Personality change ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Bladder irritation ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Bladder prolapse ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Chronic kidney disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dysuria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Haematuria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	3/11 (27.27%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/7 (14.29%)	1	0/1 (0.00%)	0	4/59 (6.78%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Incontinence ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nephrolithiasis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nocturia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Pollakiuria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Proteinuria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	3/13 (23.08%)	3	3/11 (27.27%)	4	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Renal disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Renal pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urethral atrophy ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urinary incontinence ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Urinary retention ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Urine flow decreased ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Reproductive system and breast disorders
Menstruation irregular ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cough ^† 1	3/12 (25.00%)	3	7/13 (53.85%)	11	0/2 (0.00%)	0	7/13 (53.85%)	9	3/11 (27.27%)	4	0/1 (0.00%)	0	5/12 (41.67%)	6	4/12 (33.33%)	4	0/3 (0.00%)	0	2/3 (66.67%)	2	4/12 (33.33%)	4	6/12 (50.00%)	9	1/7 (14.29%)	1	0/1 (0.00%)	0	16/59 (27.12%)	21	17/62 (27.42%)	20	0/2 (0.00%)	0	6/28 (21.43%)	7	6/33 (18.18%)	7
Dysphonia ^† 1	1/12 (8.33%)	2	4/13 (30.77%)	5	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	7	6/62 (9.68%)	6	0/2 (0.00%)	0	1/28 (3.57%)	1	4/33 (12.12%)	5
Dyspnoea ^† 1	1/12 (8.33%)	1	4/13 (30.77%)	4	0/2 (0.00%)	0	3/13 (23.08%)	3	2/11 (18.18%)	2	0/1 (0.00%)	0	3/12 (25.00%)	4	3/12 (25.00%)	3	0/3 (0.00%)	0	1/3 (33.33%)	1	3/12 (25.00%)	3	3/12 (25.00%)	4	0/7 (0.00%)	0	0/1 (0.00%)	0	24/59 (40.68%)	29	14/62 (22.58%)	16	0/2 (0.00%)	0	4/28 (14.29%)	4	8/33 (24.24%)	10
Dyspnoea exertional ^† 1	1/12 (8.33%)	1	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	4/62 (6.45%)	4	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Epistaxis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	4/13 (30.77%)	4	4/11 (36.36%)	4	0/1 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	4/62 (6.45%)	5	0/2 (0.00%)	0	2/28 (7.14%)	2	0/33 (0.00%)	0
Haemoptysis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	2/11 (18.18%)	3	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	2
Hiccups ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hypoxia ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	2	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Interstitial lung disease ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Lower respiratory tract congestion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nasal congestion ^† 1	4/12 (33.33%)	4	2/13 (15.38%)	2	0/2 (0.00%)	0	3/13 (23.08%)	4	0/11 (0.00%)	0	0/1 (0.00%)	0	3/12 (25.00%)	4	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	2/12 (16.67%)	2	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	9	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Nasal dryness ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nasal septum deviation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Oropharyngeal discomfort ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Oropharyngeal pain ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	5/62 (8.06%)	5	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Paranasal sinus discomfort ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Paranasal sinus hypersecretion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pleural effusion ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Pneumonitis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	0/62 (0.00%)	0	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Pneumothorax ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Productive cough ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Pulmonary oedema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pulmonary pain ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rhinalgia ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rhinitis allergic ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	6	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rhinorrhoea ^† 1	2/12 (16.67%)	2	1/13 (7.69%)	2	0/2 (0.00%)	0	4/13 (30.77%)	4	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	4/12 (33.33%)	4	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	7/59 (11.86%)	8	6/62 (9.68%)	6	0/2 (0.00%)	0	1/28 (3.57%)	1	2/33 (6.06%)	2
Sinus congestion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	2/11 (18.18%)	2	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Sneezing ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Upper respiratory tract congestion ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Upper-airway cough syndrome ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	4/59 (6.78%)	4	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Wheezing ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	3	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Sputum increased ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin and subcutaneous tissue disorders
Acne cystic ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Actinic keratosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/3 (33.33%)	1	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Alopecia ^† 1	7/12 (58.33%)	7	7/13 (53.85%)	7	0/2 (0.00%)	0	8/13 (61.54%)	8	8/11 (72.73%)	8	0/1 (0.00%)	0	2/12 (16.67%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	3/12 (25.00%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	12/59 (20.34%)	13	2/62 (3.23%)	2	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Alopecia areata ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dermatitis acneiform ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	5/12 (41.67%)	7	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Drug eruption ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	2	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Dry skin ^† 1	1/12 (8.33%)	1	2/13 (15.38%)	3	0/2 (0.00%)	0	2/13 (15.38%)	3	1/11 (9.09%)	1	0/1 (0.00%)	0	4/12 (33.33%)	4	2/12 (16.67%)	2	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	3/12 (25.00%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	6	5/62 (8.06%)	5	0/2 (0.00%)	0	3/28 (10.71%)	3	2/33 (6.06%)	2
Eczema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	5	1/7 (14.29%)	1	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Erythema ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hair colour changes ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Hyperhidrosis ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	4	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	2	1/33 (3.03%)	1
Ingrowing nail ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Ingrown hair ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Lichenoid keratosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Macule ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nail bed disorder ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nail discolouration ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	2	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nail disorder ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Nail ridging ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Night sweats ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	1/3 (33.33%)	1	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	0/33 (0.00%)	0
Papule ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Petechiae ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Pruritus ^† 1	1/12 (8.33%)	1	3/13 (23.08%)	3	0/2 (0.00%)	0	2/13 (15.38%)	2	1/11 (9.09%)	1	0/1 (0.00%)	0	5/12 (41.67%)	6	2/12 (16.67%)	2	1/3 (33.33%)	2	0/3 (0.00%)	0	4/12 (33.33%)	5	5/12 (41.67%)	5	3/7 (42.86%)	3	0/1 (0.00%)	0	15/59 (25.42%)	21	7/62 (11.29%)	7	0/2 (0.00%)	0	2/28 (7.14%)	4	4/33 (12.12%)	5
Rash ^† 1	3/12 (25.00%)	3	4/13 (30.77%)	6	0/2 (0.00%)	0	5/13 (38.46%)	6	3/11 (27.27%)	4	0/1 (0.00%)	0	4/12 (33.33%)	5	2/12 (16.67%)	2	0/3 (0.00%)	0	1/3 (33.33%)	1	3/12 (25.00%)	4	6/12 (50.00%)	15	2/7 (28.57%)	2	0/1 (0.00%)	0	20/59 (33.90%)	32	10/62 (16.13%)	14	0/2 (0.00%)	0	4/28 (14.29%)	4	2/33 (6.06%)	3
Rash erythematous ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash macular ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash maculo-papular ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	1/11 (9.09%)	1	0/1 (0.00%)	0	2/12 (16.67%)	2	4/12 (33.33%)	5	0/3 (0.00%)	0	1/3 (33.33%)	1	2/12 (16.67%)	4	2/12 (16.67%)	3	0/7 (0.00%)	0	0/1 (0.00%)	0	6/59 (10.17%)	6	3/62 (4.84%)	3	0/2 (0.00%)	0	2/28 (7.14%)	3	1/33 (3.03%)	2
Rash papular ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Rash pruritic ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Rosacea ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Scab ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Seborrhoeic dermatitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin discolouration ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin erosion ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin exfoliation ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	2/12 (16.67%)	2	1/7 (14.29%)	1	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin fissures ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	1/7 (14.29%)	1	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin hyperpigmentation ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin hypopigmentation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin irritation ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin lesion ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin mass ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Skin ulcer ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Urticaria ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	2/12 (16.67%)	2	0/7 (0.00%)	0	0/1 (0.00%)	0	2/59 (3.39%)	2	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Cold sweat ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Purpura ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	1/59 (1.69%)	1	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Vascular disorders
Deep vein thrombosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	1/12 (8.33%)	2	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Embolism ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	3	3/62 (4.84%)	3	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Flushing ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	2	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	5/59 (8.47%)	5	2/62 (3.23%)	2	0/2 (0.00%)	0	0/28 (0.00%)	0	2/33 (6.06%)	2
Hypertension ^† 1	2/12 (16.67%)	2	0/13 (0.00%)	0	0/2 (0.00%)	0	2/13 (15.38%)	2	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	3/12 (25.00%)	3	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	8/59 (13.56%)	15	3/62 (4.84%)	3	0/2 (0.00%)	0	1/28 (3.57%)	1	1/33 (3.03%)	1
Hypotension ^† 1	0/12 (0.00%)	0	1/13 (7.69%)	1	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	1/12 (8.33%)	1	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	3/59 (5.08%)	5	2/62 (3.23%)	2	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Orthostatic hypotension ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	2/28 (7.14%)	2	1/33 (3.03%)	1
Pelvic venous thrombosis ^† 1	1/12 (8.33%)	1	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Phlebitis ^† 1	0/12 (0.00%)	0	2/13 (15.38%)	3	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	1/62 (1.61%)	1	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Poor venous access ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	1/13 (7.69%)	1	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
Thrombophlebitis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	1/11 (9.09%)	1	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	1/33 (3.03%)	1
Venous thrombosis ^† 1	0/12 (0.00%)	0	0/13 (0.00%)	0	0/2 (0.00%)	0	0/13 (0.00%)	0	0/11 (0.00%)	0	0/1 (0.00%)	0	0/12 (0.00%)	0	0/12 (0.00%)	0	0/3 (0.00%)	0	0/3 (0.00%)	0	0/12 (0.00%)	0	1/12 (8.33%)	1	0/7 (0.00%)	0	0/1 (0.00%)	0	0/59 (0.00%)	0	0/62 (0.00%)	0	0/2 (0.00%)	0	0/28 (0.00%)	0	0/33 (0.00%)	0
1 Term from vocabulary, MedDRA 24.0 † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results.

Results Point of Contact

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Name/Title:	Senior Vice President, Global Clinical Development
Organization:	Merck Sharp & Dohme LLC
Phone:	1-800-672-6372
EMail:	ClinicalTrialsDisclosure@merck.com

Publications of Results:

Langer CJ, Gadgeel SM, Borghaei H, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Ge Y, Raftopoulos H, Gandhi L; KEYNOTE-021 investigators. Carboplatin and pemetrexed with or without pembrolizumab for advanced, non-squamous non-small-cell lung cancer: a randomised, phase 2 cohort of the open-label KEYNOTE-021 study. Lancet Oncol. 2016 Nov;17(11):1497-1508. doi: 10.1016/S1470-2045(16)30498-3. Epub 2016 Oct 10.

Borghaei H, Langer CJ, Gadgeel S, Papadimitrakopoulou VA, Patnaik A, Powell SF, Gentzler RD, Martins RG, Stevenson JP, Jalal SI, Panwalkar A, Yang JC, Gubens M, Sequist LV, Awad MM, Fiore J, Saraf S, Keller SM, Gandhi L. 24-Month Overall Survival from KEYNOTE-021 Cohort G: Pemetrexed and Carboplatin with or without Pembrolizumab as First-Line Therapy for Advanced Nonsquamous Non-Small Cell Lung Cancer. J Thorac Oncol. 2019 Jan;14(1):124-129. doi: 10.1016/j.jtho.2018.08.004. Epub 2018 Aug 21.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yang JC, Gadgeel SM, Sequist LV, Wu CL, Papadimitrakopoulou VA, Su WC, Fiore J, Saraf S, Raftopoulos H, Patnaik A. Pembrolizumab in Combination With Erlotinib or Gefitinib as First-Line Therapy for Advanced NSCLC With Sensitizing EGFR Mutation. J Thorac Oncol. 2019 Mar;14(3):553-559. doi: 10.1016/j.jtho.2018.11.028. Epub 2018 Dec 4.

Gadgeel SM, Stevenson JP, Langer CJ, Gandhi L, Borghaei H, Patnaik A, Villaruz LC, Gubens M, Hauke R, Yang JC, Sequist LV, Bachman R, Saraf S, Raftopoulos H, Papadimitrakopoulou V. Pembrolizumab and platinum-based chemotherapy as first-line therapy for advanced non-small-cell lung cancer: Phase 1 cohorts from the KEYNOTE-021 study. Lung Cancer. 2018 Nov;125:273-281. doi: 10.1016/j.lungcan.2018.08.019. Epub 2018 Aug 25.

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Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT02039674
Other Study ID Numbers:	3475-021 MK-3475-021 ( Other Identifier: Merck Protocol Number ) KEYNOTE-021 ( Other Identifier: Merck )
First Submitted:	January 16, 2014
First Posted:	January 17, 2014
Results First Submitted:	October 27, 2017
Results First Posted:	December 2, 2017
Last Update Posted:	November 8, 2022

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