Study of Pembrolizumab (MK-3475) Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (MK-3475-024/KEYNOTE-024)

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ClinicalTrials.gov Identifier: NCT02142738

Recruitment Status : Completed

First Posted : May 20, 2014

Results First Posted : July 7, 2017

Last Update Posted : June 13, 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	Drug: Pembrolizumab Drug: Paclitaxel Drug: Carboplatin Drug: Pemetrexed Drug: Cisplatin Drug: Gemcitabine
Enrollment	305

Participant Flow

Recruitment Details
Pre-assignment Details	Per protocol, it was planned that participants would be randomized 1:1 to receive either pembrolizumab or investigator-choice standard of care (SOC) chemotherapy and data analysis would be conducted on the two treatment arms: Pembrolizumab and SOC Chemotherapy.


Arm/Group Title	Pembrolizumab	SOC Chemotherapy
Arm/Group Description	Participants received pembrolizumab...	Participants received 1 of 5 possib...
Arm/Group Description	Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.	Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Period Title: Overall Study
Started	154	151
Treated	154	150
Chemotherapy Switch to Pembrolizumab	0	83
Second Course Pembrolizumab	12	1
Completed	0	0
Not Completed	154	151
Reason Not Completed
Adverse Event	13	9
Death	92	112
Lost to Follow-up	0	3
Withdrawal by Subject	6	7
Follow up ended by sponsor	43	20

Baseline Characteristics

Arm/Group Title		Pembrolizumab	SOC Chemotherapy	Total
Arm/Group Description		Participants received pembrolizumab...	Participants received 1 of 5 possib...	Total of all reporting groups
Arm/Group Description		Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).	Total of all reporting groups
Overall Number of Baseline Participants		154	151	305
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	154 participants	151 participants	305 participants
		63.9 (10.1)	64.6 (9.5)	64.2 (9.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	154 participants	151 participants	305 participants
	Female	62 40.3%	56 37.1%	118 38.7%
	Male	92 59.7%	95 62.9%	187 61.3%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	154 participants	151 participants	305 participants
	Hispanic or Latino	1 0.6%	5 3.3%	6 2.0%
	Not Hispanic or Latino	148 96.1%	135 89.4%	283 92.8%
	Unknown or Not Reported	5 3.2%	11 7.3%	16 5.2%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	154 participants	151 participants	305 participants
	American Indian or Alaska Native	0 0.0%	1 0.7%	1 0.3%
	Asian	25 16.2%	21 13.9%	46 15.1%
	Native Hawaiian or Other Pacific Islander	0 0.0%	1 0.7%	1 0.3%
	Black or African American	2 1.3%	2 1.3%	4 1.3%
	White	125 81.2%	126 83.4%	251 82.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	2 1.3%	0 0.0%	2 0.7%
Eastern Cooperative Oncology Group (ECOG) Status (0, 1 or 2) ^[1] Measure Type: Number Unit of measure: Rating	Number Analyzed	154 participants	151 participants	305 participants
ECOG = 0		54	53	107
ECOG = 1		99	98	197
ECOG = 2		1	0	1
		[1] Measure Description: Eastern Cooperative Oncology Group (ECOG) Performance. ECOG is presented where 0 = Fully active, no performance restrictions; 1 = Strenuous physical activity restricted, fully ambulatory & able to carry out light work; and 2 = In bed <50% of the time, ambulatory and capable of all self-care, but unable to carry out any work activities.
Histology ^[1] Measure Type: Number Unit of measure: Participants	Number Analyzed	154 participants	151 participants	305 participants
ADENOCARCINOMA		104	108	212
ADENOSQUAMOUS		2	2	4
LARGE CELL CARCINOMA		2	2	4
NON-SQUAMOUS CELL CARCINOMA		5	7	12
POORLY DIFFERENTIATED		9	3	12
SARCOMATOID		3	2	5
SQUAMOUS CELL CARCINOMA		29	26	55
POORLY DIFFERENTIATED SQUAMOUS CELL CARCINOMA		0	1	1
		[1] Measure Description: Participants were categorized according to the histology of their carcinoma
Geographic Region of Enrolling Site ^[1] Measure Type: Count of Participants Unit of measure: Participants	Number Analyzed	154 participants	151 participants	305 participants
Non-East Asia		133 86.4%	132 87.4%	265 86.9%
East Asia		21 13.6%	19 12.6%	40 13.1%
		[1] Measure Description: Count of Participants enrolled in sites in Non-East Asia and East Asia

Outcome Measures

1.Primary Outcome


Title	Progression Free Survival (PFS) Rate at Month 6
Description	PFS was defined as the time from randomization to documented disease p...
Description	PFS was defined as the time from randomization to documented disease progression per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) or death due to any cause, whichever occurred first and was based on blinded independent central radiologists' (BICR) review. Progressive Disease (PD) was defined as ≥20% increase in the sum of diameters of target lesions and an absolute increase of ≥5 mm. (Note: the appearance of one or more new lesions was also considered progression). Participants were evaluated every 9 weeks with radiographic imaging to assess their response to treatment. The data cutoff was 09-May-2016. The PFS rate at Month 6 was calculated.
Time Frame	Month 6

Outcome Measure Data

Analysis Population Description

The Intention-to-treat (ITT) population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.


Arm/Group Title	Pembrolizumab	SOC Chemotherapy
Arm/Group Description:	Participants received pembrolizumab...	Participants received 1 of 5 possib...
Arm/Group Description:	Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Number of Participants Analyzed	154	151
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	62.1 (53.8 to 69.4)	50.3 (41.9 to 58.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab, SOC Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	<0.001
	Comments	One-sided p-value based on log-rank test
	Method	Regression, Cox
	Comments	Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.50
	Confidence Interval	(2-Sided) 95% 0.37 to 0.68
	Estimation Comments	[Not Specified]

2.Secondary Outcome


Title	Overall Survival (OS) Rate
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. Participants without documented death at the time of the analysis were censored at the date of the last follow-up. The data cutoff was 10-July-2017. The median OS rate at 12 months is presented.
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.


Arm/Group Title	Pembrolizumab	SOC Chemotherapy
Arm/Group Description:	Participants received pembrolizumab...	Participants received 1 of 5 possib...
Arm/Group Description:	Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Number of Participants Analyzed	154	151
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	70.3 (62.3 to 76.9)	54.8 (46.4 to 62.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab, SOC Chemotherapy
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.002
	Comments	One-sided p-value based on log-rank test
	Method	Regression, Cox
	Comments	Treatment as a covariate stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)

Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.63
	Confidence Interval	(2-Sided) 95% 0.47 to 0.86
	Estimation Comments	[Not Specified]

3.Secondary Outcome


Title	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 experienced 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) and was assessed using RECIST 1.1 based on BICR evaluation. ORR was assessed from enrollment/treatment initiation of a participant through data cutoff of 09-May-2016. The ORR is presented for each treatment group.
Time Frame	Up to ~1.6 years

Outcome Measure Data

Analysis Population Description

The ITT population included all randomized participants. Participants were included in the treatment group to which they were randomized, regardless of whether or not they received study treatment.


Arm/Group Title	Pembrolizumab	SOC Chemotherapy
Arm/Group Description:	Participants received pembrolizumab...	Participants received 1 of 5 possib...
Arm/Group Description:	Participants received pembrolizumab 200 mg, administered as IV infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented PD or participant discontinuation.	Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).
Overall Number of Participants Analyzed	154	151
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Participants
	44.8 (36.8 to 53.0)	27.8 (20.8 to 35.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pembrolizumab, SOC Chemotherapy
	Comments	H0: difference in %=0 vs. H1: difference in % >0
	Type of Statistical Test	Superiority or Other (legacy)
	Comments	[Not Specified]

Statistical Test of Hypothesis	P-Value	0.0011
	Comments	One-sided p-value for testing
	Method	Miettinen & Nurminem method
	Comments	Stratified by geographic region (East Asia vs. non-East Asia), ECOG PS (0 vs. 1) and histology (squamous vs. nonsquamous)

Method of Estimation	Estimation Parameter	Difference in percentages
	Estimated Value	16.6
	Confidence Interval	(2-Sided) 95% 6.0 to 27.0
	Estimation Comments	[Not Specified]

Adverse Events

Time Frame	Up to approximately 80 months.
Adverse Event Reporting Description	All-cause mortality: All randomized participants. Safety: All randomized participants who received at least 1 dose of study treatment. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression" and "Malignant neoplasm progression" not related to study drug are excluded as AEs.

Arm/Group Title	Pembrolizumab First Course		SOC Chemotherapy First Course		SOC Chemotherapy Switched Over to Pembrolizumab First Course		Pembrolizumab Second Course		SOC Switched Over to Pembrolizumab Second Course
Arm/Group Description	Participants received pembrolizumab...		Participants received 1 of 5 possib...		Qualified participants who received...		Qualified participants who received...		One qualified participant received ...
Arm/Group Description	Participants received pembrolizumab 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle for up to 35 cycles or until documented progressive disease (PD) or participant discontinuation.		Participants received 1 of 5 possible standard chemotherapy regimens at the investigator's discretion by IV infusion: paclitaxel 200 mg/m^2 and carboplatin Area Under the Curve (AUC) 5 or 6, administered on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and carboplatin AUC 5 or 6, on Day 1 of each 21-day cycle for 4-6 cycles; pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles; gemcitabine 1250 mg/m^2, administered on Days 1 and 8 of each 21-day cycle and carboplatin AUC 5 or 6, on Day 1 of a 21-day cycle, for 4-6 cycles; gemcitabine 1250 mg/m^2, on Days 1 and 8 of each 21-day cycle and cisplatin 75 mg/m^2, on Day 1 of each 21-day cycle for 4-6 cycles or until documented PD or participant discontinuation. Participants with documented disease progression following chemotherapy can switch to receive pembrolizumab for up to 35 cycles (approximately 2 years). Eligible participants who switched to and then stopped pembrolizumab and had stable disease but progressed after discontinuation, initiated a second course of pembrolizumab at the investigator's discretion for up to 17 cycles (approximately 1 additional year).		Qualified participants who received the SOC chemotherapy first course but continued to experience disease progression, at the investigator's discretion, initiated a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to ~2 years.		Qualified participants who received the pembrolizumab first course and achieved CR, PR, or stable disease, and progressed after discontinuation, at the investigator's discretion, initiated a second course of pembrolizumab at the same dose and schedule for up to 17 cycles (approximately 1 additional year).		One qualified participant received SOC chemotherapy first course, but continued to experience disease progression and at investigator's discretion switched to a course of pembrolizumab IV 200 mg, every cycle (three weeks) for up to 35 cycles up to ~2 years. The participant then initiated a second course of pembrolizumab at the same dose and schedule for up to ~1 additional year until documented PD or participant discontinuation.
All-Cause Mortality
	Pembrolizumab First Course		SOC Chemotherapy First Course		SOC Chemotherapy Switched Over to Pembrolizumab First Course		Pembrolizumab Second Course		SOC Switched Over to Pembrolizumab Second Course
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	103/154 (66.88%)		60/151 (39.74%)		62/83 (74.70%)		4/12 (33.33%)		1/1 (100.00%)
Serious Adverse Events Serious Adverse Events
	Pembrolizumab First Course		SOC Chemotherapy First Course		SOC Chemotherapy Switched Over to Pembrolizumab First Course		Pembrolizumab Second Course		SOC Switched Over to Pembrolizumab Second Course
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	79/154 (51.30%)		70/150 (46.67%)		27/83 (32.53%)		2/12 (16.67%)		0/1 (0.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	2/154 (1.30%)	3	5/150 (3.33%)	6	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Febrile neutropenia ^† 1	0/154 (0.00%)	0	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Leukocytosis ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pancytopenia ^† 1	0/154 (0.00%)	0	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Thrombocytopenia ^† 1	0/154 (0.00%)	0	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Thrombotic microangiopathy ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cardiac disorders
Acute myocardial infarction ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Angina pectoris ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Atrial fibrillation ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Bradycardia ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cardiac arrest ^† 1	2/154 (1.30%)	2	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cardiac failure ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cardio-respiratory arrest ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Coronary artery disease ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Ischaemic cardiomyopathy ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pericardial effusion ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pericarditis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Right ventricular failure ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Supraventricular tachycardia ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Ear and labyrinth disorders
Vertigo ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Endocrine disorders
Hyperthyroidism ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypophysitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Colitis ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Constipation ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Diarrhoea ^† 1	3/154 (1.95%)	4	1/150 (0.67%)	1	3/83 (3.61%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Enterocolitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Faecaloma ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Gastric ulcer ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Gastritis ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Gastritis erosive ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Intestinal obstruction ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Nausea ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Oesophagitis ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Oral lichen planus ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Pancreatitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Small intestinal obstruction ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Stomatitis ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Vomiting ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
General disorders
Chest pain ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Death ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Face oedema ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Fatigue ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Gait disturbance ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
General physical health deterioration ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Multiple organ dysfunction syndrome ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Oedema peripheral ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pyrexia ^† 1	2/154 (1.30%)	2	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Sudden death ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hepatobiliary disorders
Acute hepatic failure ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Autoimmune hepatitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Immune system disorders
Anaphylactic reaction ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Anaphylactic shock ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypersensitivity ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Infections and infestations
Appendicitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Bronchitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Bursitis infective ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Cellulitis ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Clostridium difficile colitis ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	2/83 (2.41%)	2	0/12 (0.00%)	0	0/1 (0.00%)	0
Encephalomyelitis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Gastroenteritis viral ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Infectious pleural effusion ^† 1	2/154 (1.30%)	3	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Infective exacerbation of chronic obstructive airways disease ^† 1	2/154 (1.30%)	2	1/150 (0.67%)	1	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Lower respiratory tract infection ^† 1	5/154 (3.25%)	5	3/150 (2.00%)	3	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Lymph gland infection ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Meningitis viral ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Neutropenic sepsis ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Oral candidiasis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Peritonsillar abscess ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pneumonia ^† 1	6/154 (3.90%)	7	13/150 (8.67%)	13	2/83 (2.41%)	2	1/12 (8.33%)	1	0/1 (0.00%)	0
Pulmonary sepsis ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Respiratory tract infection ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Sepsis ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Septic shock ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Skin infection ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Splenic abscess ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Urinary tract infection ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Urosepsis ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Injury, poisoning and procedural complications
Anastomotic complication ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Infusion related reaction ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pulmonary radiation injury ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Radiation oesophagitis ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Rib fracture ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Toxicity to various agents ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	2/154 (1.30%)	3	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Aspartate aminotransferase increased ^† 1	1/154 (0.65%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Bilirubin conjugated increased ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Blood corticotrophin decreased ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Blood creatinine increased ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cortisol decreased ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Platelet count decreased ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Transaminases increased ^† 1	1/154 (0.65%)	2	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Dehydration ^† 1	1/154 (0.65%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Diabetes mellitus ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Diabetic ketoacidosis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Fluid overload ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypercalcaemia ^† 1	0/154 (0.00%)	0	3/150 (2.00%)	3	1/83 (1.20%)	2	0/12 (0.00%)	0	0/1 (0.00%)	0
Hyperglycaemia ^† 1	3/154 (1.95%)	3	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypocalcaemia ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypokalaemia ^† 1	1/154 (0.65%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hyponatraemia ^† 1	4/154 (2.60%)	5	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypovolaemia ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Type 2 diabetes mellitus ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Back pain ^† 1	1/154 (0.65%)	1	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Haematoma muscle ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Muscular weakness ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Osteolysis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Spinal pain ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Appendix cancer ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Bladder cancer ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Bladder neoplasm ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Bladder transitional cell carcinoma ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cancer pain ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Colon cancer ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Colorectal adenocarcinoma ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Infected neoplasm ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Malignant neoplasm progression ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Nervous system disorders
Brain injury ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Brown-Sequard syndrome ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cerebral haemorrhage ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cerebral infarction ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cerebrovascular accident ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Encephalopathy ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Haemorrhagic stroke ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Ischaemic stroke ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Transient ischaemic attack ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Product Issues
Device dislocation ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Psychiatric disorders
Confusional state ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Insomnia ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Restlessness ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Renal and urinary disorders
Acute kidney injury ^† 1	0/154 (0.00%)	0	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypertensive nephropathy ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Tubulointerstitial nephritis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Reproductive system and breast disorders
Ovarian haemorrhage ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Acute respiratory failure ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Atelectasis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Bronchial obstruction ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Chronic obstructive pulmonary disease ^† 1	4/154 (2.60%)	6	1/150 (0.67%)	2	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Epistaxis ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Haemoptysis ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Immune-mediated lung disease ^† 1	2/154 (1.30%)	2	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Laryngeal oedema ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Painful respiration ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pleural effusion ^† 1	6/154 (3.90%)	6	3/150 (2.00%)	3	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pneumonitis ^† 1	6/154 (3.90%)	6	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pneumothorax ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pulmonary alveolar haemorrhage ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pulmonary embolism ^† 1	2/154 (1.30%)	2	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Pulmonary oedema ^† 1	0/154 (0.00%)	0	2/150 (1.33%)	2	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Respiratory failure ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Skin and subcutaneous tissue disorders
Lichen planus ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Lichenoid keratosis ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Rash ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Rash maculo-papular ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Vascular disorders
Embolism ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Ischaemia ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Superior vena cava occlusion ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Vasospasm ^† 1	0/154 (0.00%)	0	1/150 (0.67%)	1	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
1 Term from vocabulary, MedDRA 23.1 † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Pembrolizumab First Course		SOC Chemotherapy First Course		SOC Chemotherapy Switched Over to Pembrolizumab First Course		Pembrolizumab Second Course		SOC Switched Over to Pembrolizumab Second Course
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	140/154 (90.91%)		142/150 (94.67%)		72/83 (86.75%)		10/12 (83.33%)		0/1 (0.00%)
Blood and lymphatic system disorders
Anaemia ^† 1	24/154 (15.58%)	28	77/150 (51.33%)	98	4/83 (4.82%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Leukopenia ^† 1	1/154 (0.65%)	1	10/150 (6.67%)	17	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Neutropenia ^† 1	2/154 (1.30%)	4	35/150 (23.33%)	67	1/83 (1.20%)	1	1/12 (8.33%)	1	0/1 (0.00%)	0
Thrombocytopenia ^† 1	2/154 (1.30%)	2	18/150 (12.00%)	32	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Cardiac disorders
Bradycardia ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Endocrine disorders
Hyperthyroidism ^† 1	10/154 (6.49%)	11	2/150 (1.33%)	3	5/83 (6.02%)	7	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypothyroidism ^† 1	16/154 (10.39%)	16	3/150 (2.00%)	3	8/83 (9.64%)	8	1/12 (8.33%)	1	0/1 (0.00%)	0
Eye disorders
Conjunctivitis allergic ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	1/83 (1.20%)	1	1/12 (8.33%)	1	0/1 (0.00%)	0
Gastrointestinal disorders
Abdominal pain ^† 1	14/154 (9.09%)	17	10/150 (6.67%)	10	7/83 (8.43%)	7	1/12 (8.33%)	1	0/1 (0.00%)	0
Abdominal pain upper ^† 1	7/154 (4.55%)	9	7/150 (4.67%)	13	2/83 (2.41%)	2	1/12 (8.33%)	1	0/1 (0.00%)	0
Constipation ^† 1	35/154 (22.73%)	43	33/150 (22.00%)	54	7/83 (8.43%)	7	2/12 (16.67%)	2	0/1 (0.00%)	0
Diarrhoea ^† 1	41/154 (26.62%)	65	33/150 (22.00%)	43	18/83 (21.69%)	22	1/12 (8.33%)	1	0/1 (0.00%)	0
Dyspepsia ^† 1	6/154 (3.90%)	7	9/150 (6.00%)	14	3/83 (3.61%)	3	1/12 (8.33%)	2	0/1 (0.00%)	0
Dysphagia ^† 1	2/154 (1.30%)	2	6/150 (4.00%)	6	3/83 (3.61%)	3	1/12 (8.33%)	1	0/1 (0.00%)	0
Nausea ^† 1	33/154 (21.43%)	44	68/150 (45.33%)	129	15/83 (18.07%)	19	1/12 (8.33%)	1	0/1 (0.00%)	0
Oesophagitis ^† 1	1/154 (0.65%)	1	1/150 (0.67%)	1	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Stomatitis ^† 1	8/154 (5.19%)	8	17/150 (11.33%)	23	3/83 (3.61%)	3	0/12 (0.00%)	0	0/1 (0.00%)	0
Vomiting ^† 1	16/154 (10.39%)	20	36/150 (24.00%)	65	8/83 (9.64%)	9	0/12 (0.00%)	0	0/1 (0.00%)	0
General disorders
Asthenia ^† 1	12/154 (7.79%)	17	17/150 (11.33%)	30	7/83 (8.43%)	7	0/12 (0.00%)	0	0/1 (0.00%)	0
Chest pain ^† 1	16/154 (10.39%)	17	16/150 (10.67%)	16	5/83 (6.02%)	6	0/12 (0.00%)	0	0/1 (0.00%)	0
Fatigue ^† 1	37/154 (24.03%)	45	53/150 (35.33%)	93	18/83 (21.69%)	19	1/12 (8.33%)	1	0/1 (0.00%)	0
Influenza like illness ^† 1	2/154 (1.30%)	2	2/150 (1.33%)	7	3/83 (3.61%)	4	1/12 (8.33%)	1	0/1 (0.00%)	0
Malaise ^† 1	6/154 (3.90%)	6	12/150 (8.00%)	13	1/83 (1.20%)	2	0/12 (0.00%)	0	0/1 (0.00%)	0
Oedema peripheral ^† 1	19/154 (12.34%)	20	15/150 (10.00%)	19	3/83 (3.61%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Pyrexia ^† 1	27/154 (17.53%)	36	14/150 (9.33%)	16	8/83 (9.64%)	8	0/12 (0.00%)	0	0/1 (0.00%)	0
Infections and infestations
Bronchitis ^† 1	8/154 (5.19%)	9	4/150 (2.67%)	5	5/83 (6.02%)	6	0/12 (0.00%)	0	0/1 (0.00%)	0
Infected dermal cyst ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Influenza ^† 1	2/154 (1.30%)	2	2/150 (1.33%)	3	1/83 (1.20%)	1	1/12 (8.33%)	1	0/1 (0.00%)	0
Nasopharyngitis ^† 1	18/154 (11.69%)	27	2/150 (1.33%)	2	9/83 (10.84%)	10	2/12 (16.67%)	2	0/1 (0.00%)	0
Sinusitis ^† 1	2/154 (1.30%)	2	2/150 (1.33%)	2	2/83 (2.41%)	2	1/12 (8.33%)	1	0/1 (0.00%)	0
Tooth infection ^† 1	2/154 (1.30%)	2	2/150 (1.33%)	2	2/83 (2.41%)	3	1/12 (8.33%)	1	0/1 (0.00%)	0
Upper respiratory tract infection ^† 1	11/154 (7.14%)	18	5/150 (3.33%)	7	9/83 (10.84%)	12	4/12 (33.33%)	4	0/1 (0.00%)	0
Urinary tract infection ^† 1	9/154 (5.84%)	11	8/150 (5.33%)	11	4/83 (4.82%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Injury, poisoning and procedural complications
Eye injury ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Fall ^† 1	9/154 (5.84%)	9	4/150 (2.67%)	4	3/83 (3.61%)	5	0/12 (0.00%)	0	0/1 (0.00%)	0
Ligament sprain ^† 1	2/154 (1.30%)	2	1/150 (0.67%)	1	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Investigations
Alanine aminotransferase increased ^† 1	17/154 (11.04%)	20	11/150 (7.33%)	15	4/83 (4.82%)	4	1/12 (8.33%)	1	0/1 (0.00%)	0
Aspartate aminotransferase increased ^† 1	15/154 (9.74%)	19	7/150 (4.67%)	9	4/83 (4.82%)	4	1/12 (8.33%)	1	0/1 (0.00%)	0
Blood alkaline phosphatase increased ^† 1	10/154 (6.49%)	14	4/150 (2.67%)	4	2/83 (2.41%)	2	1/12 (8.33%)	1	0/1 (0.00%)	0
Blood creatinine increased ^† 1	12/154 (7.79%)	15	21/150 (14.00%)	26	5/83 (6.02%)	9	0/12 (0.00%)	0	0/1 (0.00%)	0
Neutrophil count decreased ^† 1	1/154 (0.65%)	3	21/150 (14.00%)	37	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Platelet count decreased ^† 1	1/154 (0.65%)	1	19/150 (12.67%)	28	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Weight decreased ^† 1	14/154 (9.09%)	15	11/150 (7.33%)	12	6/83 (7.23%)	8	2/12 (16.67%)	2	0/1 (0.00%)	0
White blood cell count decreased ^† 1	1/154 (0.65%)	3	17/150 (11.33%)	25	1/83 (1.20%)	1	1/12 (8.33%)	1	0/1 (0.00%)	0
Metabolism and nutrition disorders
Decreased appetite ^† 1	33/154 (21.43%)	36	49/150 (32.67%)	71	12/83 (14.46%)	13	2/12 (16.67%)	2	0/1 (0.00%)	0
Hyperglycaemia ^† 1	10/154 (6.49%)	17	9/150 (6.00%)	10	2/83 (2.41%)	3	0/12 (0.00%)	0	0/1 (0.00%)	0
Hyperkalaemia ^† 1	8/154 (5.19%)	9	6/150 (4.00%)	7	3/83 (3.61%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypoalbuminaemia ^† 1	8/154 (5.19%)	8	7/150 (4.67%)	7	3/83 (3.61%)	6	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypomagnesaemia ^† 1	4/154 (2.60%)	7	13/150 (8.67%)	18	5/83 (6.02%)	5	1/12 (8.33%)	1	0/1 (0.00%)	0
Hyponatraemia ^† 1	11/154 (7.14%)	17	12/150 (8.00%)	13	7/83 (8.43%)	8	0/12 (0.00%)	0	0/1 (0.00%)	0
Musculoskeletal and connective tissue disorders
Arthralgia ^† 1	34/154 (22.08%)	47	17/150 (11.33%)	21	16/83 (19.28%)	18	0/12 (0.00%)	0	0/1 (0.00%)	0
Back pain ^† 1	23/154 (14.94%)	26	18/150 (12.00%)	21	4/83 (4.82%)	4	0/12 (0.00%)	0	0/1 (0.00%)	0
Muscle spasms ^† 1	10/154 (6.49%)	10	2/150 (1.33%)	2	2/83 (2.41%)	3	0/12 (0.00%)	0	0/1 (0.00%)	0
Myalgia ^† 1	10/154 (6.49%)	11	2/150 (1.33%)	2	5/83 (6.02%)	5	0/12 (0.00%)	0	0/1 (0.00%)	0
Pain in extremity ^† 1	9/154 (5.84%)	12	10/150 (6.67%)	13	6/83 (7.23%)	8	1/12 (8.33%)	1	0/1 (0.00%)	0
Periarthritis ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain ^† 1	1/154 (0.65%)	1	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Nervous system disorders
Dizziness ^† 1	20/154 (12.99%)	25	12/150 (8.00%)	16	5/83 (6.02%)	7	0/12 (0.00%)	0	0/1 (0.00%)	0
Dysgeusia ^† 1	2/154 (1.30%)	2	13/150 (8.67%)	13	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Headache ^† 1	11/154 (7.14%)	17	7/150 (4.67%)	8	7/83 (8.43%)	7	0/12 (0.00%)	0	0/1 (0.00%)	0
Neuropathy peripheral ^† 1	2/154 (1.30%)	2	10/150 (6.67%)	10	3/83 (3.61%)	3	0/12 (0.00%)	0	0/1 (0.00%)	0
Tremor ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Psychiatric disorders
Insomnia ^† 1	16/154 (10.39%)	18	11/150 (7.33%)	11	7/83 (8.43%)	7	0/12 (0.00%)	0	0/1 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Cough ^† 1	29/154 (18.83%)	44	21/150 (14.00%)	24	16/83 (19.28%)	17	1/12 (8.33%)	1	0/1 (0.00%)	0
Dyspnoea ^† 1	41/154 (26.62%)	50	24/150 (16.00%)	29	9/83 (10.84%)	10	0/12 (0.00%)	0	0/1 (0.00%)	0
Haemoptysis ^† 1	11/154 (7.14%)	11	5/150 (3.33%)	5	7/83 (8.43%)	10	1/12 (8.33%)	1	0/1 (0.00%)	0
Hiccups ^† 1	2/154 (1.30%)	2	10/150 (6.67%)	12	1/83 (1.20%)	1	0/12 (0.00%)	0	0/1 (0.00%)	0
Nasal congestion ^† 1	1/154 (0.65%)	1	2/150 (1.33%)	2	3/83 (3.61%)	3	1/12 (8.33%)	1	0/1 (0.00%)	0
Skin and subcutaneous tissue disorders
Alopecia ^† 1	2/154 (1.30%)	2	15/150 (10.00%)	15	2/83 (2.41%)	2	0/12 (0.00%)	0	0/1 (0.00%)	0
Dry skin ^† 1	17/154 (11.04%)	18	1/150 (0.67%)	1	7/83 (8.43%)	7	1/12 (8.33%)	1	0/1 (0.00%)	0
Panniculitis ^† 1	0/154 (0.00%)	0	0/150 (0.00%)	0	0/83 (0.00%)	0	1/12 (8.33%)	1	0/1 (0.00%)	0
Pruritus ^† 1	32/154 (20.78%)	46	6/150 (4.00%)	6	13/83 (15.66%)	13	2/12 (16.67%)	2	0/1 (0.00%)	0
Rash ^† 1	28/154 (18.18%)	43	7/150 (4.67%)	8	8/83 (9.64%)	13	0/12 (0.00%)	0	0/1 (0.00%)	0
Rash maculo-papular ^† 1	7/154 (4.55%)	8	1/150 (0.67%)	2	6/83 (7.23%)	6	0/12 (0.00%)	0	0/1 (0.00%)	0
Vascular disorders
Hypertension ^† 1	11/154 (7.14%)	13	4/150 (2.67%)	4	0/83 (0.00%)	0	0/12 (0.00%)	0	0/1 (0.00%)	0
Hypotension ^† 1	4/154 (2.60%)	5	4/150 (2.67%)	4	2/83 (2.41%)	2	1/12 (8.33%)	1	0/1 (0.00%)	0
1 Term from vocabulary, MedDRA 23.1 † 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

Layout table for Results Point of Contact information

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:

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR for the KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1 Positive Non-Small-Cell Lung Cancer . N Engl J Med. 2016;[e published 09 Oct 2016]. doi: 10.1056/NEJMoa1606774

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

Halmos B, Burke T, Kalyvas C, Insinga R, Vandormael K, Frederickson A, Piperdi B. Indirect comparison of pembrolizumab monotherapy versus nivolumab + ipilimumab in first-line metastatic lung cancer. Immunotherapy. 2022 Apr;14(5):295-307. doi: 10.2217/imt-2021-0273. Epub 2022 Jan 25.

Satouchi M, Nosaki K, Takahashi T, Nakagawa K, Aoe K, Kurata T, Sekine A, Horiike A, Fukuhara T, Sugawara S, Umemura S, Saka H, Okamoto I, Yamamoto N, Sakai H, Kishi K, Katakami N, Horinouchi H, Hida T, Okamoto H, Atagi S, Ohira T, Rong Han S, Noguchi K, Ebiana V, Hotta K. First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. Cancer Sci. 2021 Dec;112(12):5000-5010. doi: 10.1111/cas.15144. Epub 2021 Nov 5.

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leal TA, Riess JW, Jensen E, Zhao B, Pietanza MC, Brahmer JR. Five-Year Outcomes With Pembrolizumab Versus Chemotherapy for Metastatic Non-Small-Cell Lung Cancer With PD-L1 Tumor Proportion Score >/= 50. J Clin Oncol. 2021 Jul 20;39(21):2339-2349. doi: 10.1200/JCO.21.00174. Epub 2021 Apr 19.

Satouchi M, Nosaki K, Takahashi T, Nakagawa K, Aoe K, Kurata T, Sekine A, Horiike A, Fukuhara T, Sugawara S, Umemura S, Saka H, Okamoto I, Yamamoto N, Sakai H, Kishi K, Katakami N, Horinouchi H, Hida T, Okamoto H, Atagi S, Ohira T, Han SR, Noguchi K, Ebiana V, Hotta K. First-line pembrolizumab vs chemotherapy in metastatic non-small-cell lung cancer: KEYNOTE-024 Japan subset. Cancer Sci. 2020 Dec;111(12):4480-4489. doi: 10.1111/cas.14647. Epub 2020 Oct 16.

Retraction in: Cancer Sci. 2021 Aug;112(8):3403

Lala M, Li TR, de Alwis DP, Sinha V, Mayawala K, Yamamoto N, Siu LL, Chartash E, Aboshady H, Jain L. A six-weekly dosing schedule for pembrolizumab in patients with cancer based on evaluation using modelling and simulation. Eur J Cancer. 2020 May;131:68-75. doi: 10.1016/j.ejca.2020.02.016. Epub 2020 Apr 15. Erratum In: Eur J Cancer. 2021 Feb;144:400.

Bhadhuri A, Insinga R, Guggisberg P, Panje C, Schwenkglenks M. Cost effectiveness of pembrolizumab vs chemotherapy as first-line treatment for metastatic NSCLC that expresses high levels of PD-L1 in Switzerland. Swiss Med Wkly. 2019 Dec 27;149:w20170. doi: 10.4414/smw.2019.20170. eCollection 2019 Dec 16.

van Vugt MJH, Stone JA, De Greef RHJMM, Snyder ES, Lipka L, Turner DC, Chain A, Lala M, Li M, Robey SH, Kondic AG, De Alwis D, Mayawala K, Jain L, Freshwater T. Immunogenicity of pembrolizumab in patients with advanced tumors. J Immunother Cancer. 2019 Aug 8;7(1):212. doi: 10.1186/s40425-019-0663-4.

Brahmer JR, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Zhang J, Lubiniecki GM, Deitz AC, Rangwala R, Reck M. Health-related quality-of-life results for pembrolizumab versus chemotherapy in advanced, PD-L1-positive NSCLC (KEYNOTE-024): a multicentre, international, randomised, open-label phase 3 trial. Lancet Oncol. 2017 Dec;18(12):1600-1609. doi: 10.1016/S1470-2045(17)30690-3. Epub 2017 Nov 9.

Reck M, Rodriguez-Abreu D, Robinson AG, Hui R, Csoszi T, Fulop A, Gottfried M, Peled N, Tafreshi A, Cuffe S, O'Brien M, Rao S, Hotta K, Leiby MA, Lubiniecki GM, Shentu Y, Rangwala R, Brahmer JR; KEYNOTE-024 Investigators. Pembrolizumab versus Chemotherapy for PD-L1-Positive Non-Small-Cell Lung Cancer. N Engl J Med. 2016 Nov 10;375(19):1823-1833. doi: 10.1056/NEJMoa1606774. Epub 2016 Oct 8.

Layout table for additonal information

Responsible Party:	Merck Sharp & Dohme LLC
ClinicalTrials.gov Identifier:	NCT02142738
Other Study ID Numbers:	3475-024 142728 ( Registry Identifier: JAPIC ) MK-3475-024 ( Other Identifier: Merck Protocol Number ) 2014-000323-25 ( EudraCT Number )
First Submitted:	May 16, 2014
First Posted:	May 20, 2014
Results First Submitted:	April 14, 2017
Results First Posted:	July 7, 2017
Last Update Posted:	June 13, 2022

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