A Phase 2 Open-Label Study of the Efficacy and Safety of ABT-199 (GDC-0199) in Chronic Lymphocytic Leukemia (CLL) Subjects With Relapse or Refractory to B-Cell Receptor Signaling Pathway Inhibitor Therapy

• ClinicalTrials.gov Identifier: NCT02141282
• Recruitment Status: Completed
• First Posted: May 19, 2014
• Results First Posted: December 19, 2022
• Last Update Posted: December 19, 2022
• Sponsor: AbbVie
• Collaborator: Roche-Genentech
• Information provided by (Responsible Party): AbbVie

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Chronic Lymphocytic Leukemia
• Intervention: Drug: Venetoclax
• Enrollment: 127

Participant Flow

Recruitment Details
Pre-assignment Details	Safety population: all participants who received at least one dose of venetoclax

Arm/Group Title	ABT-199 After Ibrutinib Therapy	ABT-199 After Idelalisib Therapy	ABT-199 After Ibrutinib Therapy: Expansion Cohort	ABT-199 After Idelalisib Therapy: Expansion Cohort
Arm/Group Description	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.
Period Title: Overall Study
Started	43	21	48	15
Completed	0	0	0	0
Not Completed	43	21	48	15
Reason Not Completed
Adverse event, not related to progression	8	1	3	1
Adverse event, related to progression	1	0	2	0
COVID-19 infection	1	0	0	0
Lost to Follow-up	0	0	4	2
Other, not specified	14	11	23	9
Progressive disease, Richter's	4	1	1	1
Progressive disease per protocol	12	7	9	2
Stem cell transplant	1	0	1	0
Study terminated by Sponsor	0	1	0	0
Subject non-compliance	0	0	1	0
Withdrew consent	2	0	4	0

Baseline Characteristics

Arm/Group Title		ABT-199 After Ibrutinib Therapy	ABT-199 After Idelalisib Therapy	ABT-199 After Ibrutinib Therapy: Expansion Cohort	ABT-199 After Idelalisib Therapy: Expansion Cohort	Total
Arm/Group Description		Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 593 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1023 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 622 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) received venetoclax tablets once daily (QD) until disease progression or study drug discontinuation; median time on treatment was 1189 days. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants enrolled into the Expansion Cohort with bulky disease at study entry who were non-responders or those who showed signs of clinical progression after completing the ramp up to 400 mg either by clinical disease assessment or by CT/MRI scan between Week 6 to Week 12 may have been permitted to escalate venetoclax to a daily dose of 600 mg.	Total of all reporting groups
Overall Number of Baseline Participants		43	21	48	15	127
Baseline Analysis Population Description		All treated participants
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	43 participants	21 participants	48 participants	15 participants	127 participants
		65.7 (8.74)	68.0 (7.26)	64.2 (10.72)	68.7 (8.35)	65.9 (9.34)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	43 participants	21 participants	48 participants	15 participants	127 participants
	Female	10	6	17	5	38
	Male	33	15	31	10	89
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	43 participants	21 participants	48 participants	15 participants	127 participants
White		40	19	45	13	117
Black		2	2	3	1	8
Asian		1	0	0	1	2
American Indian/Alaska native		0	0	0	0	0
Native Hawaiian or other Pacific Islander		0	0	0	0	0
Other		0	0	0	0	0
Multi race		0	0	0	0	0

Outcome Measures

1. Primary Outcome

Title	Overall Response Rate (ORR)
Description	Overall response rate is defined as the percentage of participants with an overall response (per the investigator assessment) 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL) National Cancer Institute-Working Group (NCI-WG) criteria.
Time Frame	At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

Outcome Measure Data

Analysis Population Description

All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	64.8; (54.1 to 74.6)	69.4; (51.9 to 83.7)

2. Secondary Outcome

Title	Duration of Response (DOR)
Description	DOR is defined as the number of days from the date of first response (complete response [CR], complete response with incomplete marrow recovery [CRi], nodular partial remission [nPR], or partial remission [PR]) to the earliest recurrence or progressive disease. DOR was analyzed by Kaplan-Meier (K-M) methodology.
Time Frame	At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

Outcome Measure Data

Analysis Population Description

All enrolled participants who received venetoclax, had active disease at baseline, and achieved a response of PR or better

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	59	25
Median (95% Confidence Interval); Unit of Measure: months
	35.1; (19.4 to 50.5)	55.4 [1]; (32.0 to NA)

[1]

Not calculable/estimable due to low number of participants with events

3. Secondary Outcome

Title	Time to Progression (TTP)
Description	TTP is defined as the number of days from the date of first dose to the date of earliest disease progression (PD). TTP was analyzed by Kaplan-Meier (K-M) methodology.
Time Frame	At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

Outcome Measure Data

Analysis Population Description

All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Median (95% Confidence Interval); Unit of Measure: months
	36.1; (21.9 to 49.0)	43.4 [1]; (20.1 to NA)

[1]

Not calculable/estimable due to low number of participants with events

4. Secondary Outcome

Title	Progression-free Survival (PFS)
Description	PFS is defined as the number of days from the date of first dose to the date of earliest disease progression (PD) or death. PFS was analyzed by Kaplan-Meier methodology.
Time Frame	At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

Outcome Measure Data

Analysis Population Description

All enrolled participants who received venetoclax and had active disease at baseline

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Median (95% Confidence Interval); Unit of Measure: months
	24.7; (19.2 to 40.9)	43.4 [1]; (20.1 to NA)

[1]

Not calculable/estimable due to low number of participants with events

5. Secondary Outcome

Title	Overall Survival (OS)
Description	OS is defined as the number of days from the date of first dose to the date of death for all dosed participants. For participants who did not die, their data was censored at the date of last study visit or the last known date to be alive, whichever was later. OS was estimated using Kaplan-Meier methodology.
Time Frame	At Wk 5, Day 1; Wk 8, Day 1; Wk 12, Day 1; Wk 16, Day 1; Wk 20, Day 1; Wk 24, Day 1; Wk 36, Day 1; every 12 wks after Wk 36; Final Visit; estimated median time on follow-up was 1694 d for ibrutinib failure cohort and 1942 d for idelalisib failure cohort

Outcome Measure Data

Analysis Population Description

All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Median (95% Confidence Interval); Unit of Measure: months
	69.6 [1]; (51.3 to NA)	NA [1]; (57.2 to NA)

[1]

Not calculable/estimable due to low number of participants with events

6. Other Pre-specified Outcome

Title	Time to Next Anti-Chronic Lymphocytic Leukemia Treatment (TNNT)
Description	TNNT is defined as the number of days from the date of the first dose of venetoclax to the date of first dose of any non-protocol anti-leukemia therapy (NPT) or death from any cause. For participants who did not take NPT, their data was censored at the last known date to be free of NPT. TTNT was analyzed by Kaplan-Meier methodology.
Time Frame	Collected every 3 months for a period of 5 years after the last participant had enrolled into the study

Outcome Measure Data

Analysis Population Description

All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Median (95% Confidence Interval); Unit of Measure: months
	24.0; (18.7 to 40.9)	37.8 [1]; (17.1 to NA)

[1]

Not calculable/estimable due to low number of participants with events

7. Other Pre-specified Outcome

Title	Percentage of Participants With Minimal Residual Disease (MRD) Negativity Status
Description	The rate of MRD response is defined as the percentage of participants who had MRD negative status.
Time Frame	Assessed at Week 24, Day 1; after the first Complete Response, Complete Remission with Incomplete Marrow Recovery, or Partial Response; at 12-week interval visits until two consecutive negative MRD levels were reported

Outcome Measure Data

Analysis Population Description

All participants in the Main and Expansion Cohorts who received at least one dose of venetoclax; indeterminate or missing samples were considered MRD positive for the calculation

Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts	ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts
Arm/Group Description:	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts	Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts
Overall Number of Participants Analyzed	91	36
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
Peripheral blood	30.8; (21.5 to 41.3)	25.0; (12.1 to 42.2)
Bone marrow	6.6; (2.5 to 13.8)	11.1; (3.1 to 26.1)

Adverse Events

Time Frame	All-cause mortality reported from enrollment to 30 d after last dose of study drug; median time on follow up was up to 1694 d for those with ibrutinib-resistant or refractory CLL and up to 1942 d for those with idelalisib-resistant or refractory CLL. TEAEs and SAEs collected from first dose of study drug until 30 d after last dose of study drug; mean duration on study drug was 819.8 d (ibrutinib-resistant or refractory CLL cohorts) and 1151.5 d (idelalisib-resistant or refractory CLL cohorts).
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	ABT-199 After Ibrutinib Therapy: Main Cohort		ABT-199 After Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib Therapy: Expansion Cohort		ABT-199 After Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts		ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts		All Participants
Arm/Group Description	Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort		Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main Cohort		Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Main Cohort		Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort		Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort		Participants with ibrutinib-resistant/refractory or idelalisib-resistant/refractory chronic lymphocytic leukemia (CLL) in the Expansion Cohort		Participants with ibrutinib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts		Participants with idelalisib-resistant or refractory chronic lymphocytic leukemia (CLL) in the Main and Expansion Cohorts		All participants in the Main and Expansion Cohorts
All-Cause Mortality
	ABT-199 After Ibrutinib Therapy: Main Cohort		ABT-199 After Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib Therapy: Expansion Cohort		ABT-199 After Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts		ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts		All Participants
	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	25/43 (58.14%)		9/21 (42.86%)		34/64 (53.13%)		17/48 (35.42%)		4/15 (26.67%)		21/63 (33.33%)		42/91 (46.15%)		13/36 (36.11%)		55/127 (43.31%)
Serious Adverse Events
	ABT-199 After Ibrutinib Therapy: Main Cohort		ABT-199 After Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib Therapy: Expansion Cohort		ABT-199 After Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts		ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts		All Participants
	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	35/43 (81.40%)		14/21 (66.67%)		49/64 (76.56%)		26/48 (54.17%)		9/15 (60.00%)		35/63 (55.56%)		61/91 (67.03%)		23/36 (63.89%)		84/127 (66.14%)
Blood and lymphatic system disorders
ANAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	1/15 (6.67%)	1	2/63 (3.17%)	2	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
AUTOIMMUNE HAEMOLYTIC ANAEMIA † 1	1/43 (2.33%)	2	0/21 (0.00%)	0	1/64 (1.56%)	2	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	3	0/36 (0.00%)	0	2/127 (1.57%)	3
FEBRILE NEUTROPENIA † 1	10/43 (23.26%)	13	1/21 (4.76%)	1	11/64 (17.19%)	14	3/48 (6.25%)	4	0/15 (0.00%)	0	3/63 (4.76%)	4	13/91 (14.29%)	17	1/36 (2.78%)	1	14/127 (11.02%)	18
HAEMOLYTIC ANAEMIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
LYMPHOPENIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
NEUTROPENIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
THROMBOCYTOPENIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Cardiac disorders
ANGINA UNSTABLE † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
ATRIAL FIBRILLATION † 1	0/43 (0.00%)	0	1/21 (4.76%)	2	1/64 (1.56%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	2	1/127 (0.79%)	2
ATRIAL FLUTTER † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
CARDIAC FAILURE CONGESTIVE † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
MYOCARDIAL INFARCTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
VENTRICULAR TACHYCARDIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Gastrointestinal disorders
ABDOMINAL PAIN LOWER † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DIARRHOEA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DYSPEPSIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DYSPHAGIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
EROSIVE OESOPHAGITIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
GASTRIC ULCER † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
INCARCERATED INGUINAL HERNIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
INTESTINAL ISCHAEMIA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
INTESTINAL OBSTRUCTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
MESENTERIC VEIN THROMBOSIS † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
MOUTH HAEMORRHAGE † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
SMALL INTESTINAL OBSTRUCTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	1/48 (2.08%)	2	0/15 (0.00%)	0	1/63 (1.59%)	2	2/91 (2.20%)	3	0/36 (0.00%)	0	2/127 (1.57%)	3
STOMATITIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
UPPER GASTROINTESTINAL HAEMORRHAGE † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
General disorders
ASTHENIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
CHEST PAIN † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	1/15 (6.67%)	1	2/63 (3.17%)	2	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
DEATH † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DISEASE PROGRESSION † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
FACIAL PAIN † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
FATIGUE † 1	1/43 (2.33%)	1	1/21 (4.76%)	1	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
MULTIPLE ORGAN DYSFUNCTION SYNDROME † 1	1/43 (2.33%)	1	1/21 (4.76%)	1	2/64 (3.13%)	2	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
PYREXIA † 1	0/43 (0.00%)	0	2/21 (9.52%)	2	2/64 (3.13%)	2	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	2/91 (2.20%)	2	3/36 (8.33%)	3	5/127 (3.94%)	5
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
Hepatobiliary disorders
BILE DUCT STONE † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
CHOLECYSTITIS ACUTE † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
Immune system disorders
CYTOKINE RELEASE SYNDROME † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
Infections and infestations
APPENDICITIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
ARTHRITIS BACTERIAL † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
BACTERAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	3/48 (6.25%)	3	0/15 (0.00%)	0	3/63 (4.76%)	3	3/91 (3.30%)	3	0/36 (0.00%)	0	3/127 (2.36%)	3
BRONCHITIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
CELLULITIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	2/48 (4.17%)	3	0/15 (0.00%)	0	2/63 (3.17%)	3	2/91 (2.20%)	3	0/36 (0.00%)	0	2/127 (1.57%)	3
CORYNEBACTERIUM BACTERAEMIA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
CORYNEBACTERIUM SEPSIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DIVERTICULITIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
ESCHERICHIA BACTERAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
ESCHERICHIA SEPSIS † 1	1/43 (2.33%)	2	0/21 (0.00%)	0	1/64 (1.56%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	2	0/36 (0.00%)	0	1/127 (0.79%)	2
GASTROENTERITIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
GASTROENTERITIS VIRAL † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
INFLUENZA † 1	0/43 (0.00%)	0	2/21 (9.52%)	2	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	2/36 (5.56%)	2	2/127 (1.57%)	2
LYMPH GLAND INFECTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PAROTITIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PHARYNGITIS † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
PNEUMONIA † 1	6/43 (13.95%)	8	3/21 (14.29%)	8	9/64 (14.06%)	16	3/48 (6.25%)	4	1/15 (6.67%)	1	4/63 (6.35%)	5	9/91 (9.89%)	12	4/36 (11.11%)	9	13/127 (10.24%)	21
PNEUMONIA ASPIRATION † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PNEUMONIA BACTERIAL † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
PNEUMONIA LEGIONELLA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
PNEUMONIA PSEUDOMONAL † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	2	0/15 (0.00%)	0	1/63 (1.59%)	2	1/91 (1.10%)	2	0/36 (0.00%)	0	1/127 (0.79%)	2
PNEUMONIA VIRAL † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
RHINOVIRUS INFECTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
SEPSIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	2/15 (13.33%)	2	3/63 (4.76%)	3	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
SEPTIC SHOCK † 1	1/43 (2.33%)	1	1/21 (4.76%)	1	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
STAPHYLOCOCCAL BACTERAEMIA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
STREPTOCOCCAL BACTERAEMIA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
URINARY TRACT INFECTION † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
WOUND INFECTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Injury, poisoning and procedural complications
FALL † 1	1/43 (2.33%)	1	1/21 (4.76%)	1	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
JOINT DISLOCATION † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
PELVIC FRACTURE † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
POST PROCEDURAL HAEMATURIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
Investigations
ALANINE AMINOTRANSFERASE INCREASED † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
BLOOD CREATININE INCREASED † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
BLOOD GLUCOSE INCREASED † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
BLOOD POTASSIUM INCREASED † 1	2/43 (4.65%)	2	0/21 (0.00%)	0	2/64 (3.13%)	2	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	2/91 (2.20%)	2	1/36 (2.78%)	1	3/127 (2.36%)	3
Metabolism and nutrition disorders
DEHYDRATION † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
HYPERCALCAEMIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	4/91 (4.40%)	4	1/36 (2.78%)	1	5/127 (3.94%)	5
HYPERKALAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
HYPERPHOSPHATAEMIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
HYPERVOLAEMIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Musculoskeletal and connective tissue disorders
ARTHRITIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
BACK PAIN † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
GROIN PAIN † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
INTERVERTEBRAL DISC PROTRUSION † 1	2/43 (4.65%)	2	0/21 (0.00%)	0	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
LUMBAR SPINAL STENOSIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
SPINAL STENOSIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ADENOCARCINOMA OF COLON † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
BASAL CELL CARCINOMA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	1/36 (2.78%)	1	2/127 (1.57%)	2
BLADDER CANCER † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
CHRONIC LYMPHOCYTIC LEUKAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
HIGH-GRADE B-CELL LYMPHOMA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
MALIGNANT NEOPLASM PROGRESSION † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
METASTASES TO MENINGES † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
MUCOEPIDERMOID CARCINOMA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
MYELODYSPLASTIC SYNDROME † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PROSTATE CANCER † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
RICHTER'S SYNDROME † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
SALIVARY GLAND CANCER † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Nervous system disorders
CAUDA EQUINA SYNDROME † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
CEREBROVASCULAR ACCIDENT † 1	2/43 (4.65%)	2	0/21 (0.00%)	0	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
HAEMORRHAGE INTRACRANIAL † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PARAESTHESIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PRESYNCOPE † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	2	0/36 (0.00%)	0	2/127 (1.57%)	2
SEIZURE † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Renal and urinary disorders
ACUTE KIDNEY INJURY † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
BLADDER OUTLET OBSTRUCTION † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
NEPHROLITHIASIS † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
RENAL FAILURE † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
URINARY TRACT OBSTRUCTION † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
Reproductive system and breast disorders
BENIGN PROSTATIC HYPERPLASIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
PROSTATIC OBSTRUCTION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
ASPHYXIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
DYSPNOEA † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	2/36 (5.56%)	2	2/127 (1.57%)	2
HAEMOPTYSIS † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
HYPOXIA † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PLEURAL EFFUSION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
PULMONARY EMBOLISM † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
PULMONARY GRANULOMA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
RESPIRATORY FAILURE † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	0/91 (0.00%)	0	2/36 (5.56%)	2	2/127 (1.57%)	2
Skin and subcutaneous tissue disorders
DRUG ERUPTION † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	1/36 (2.78%)	1	1/127 (0.79%)	1
EOSINOPHILIC CELLULITIS † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
Vascular disorders
ORTHOSTATIC HYPOTENSION † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	0/36 (0.00%)	0	1/127 (0.79%)	1
1 Term from vocabulary, MedDRA 24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	ABT-199 After Ibrutinib Therapy: Main Cohort		ABT-199 After Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Main Cohort		ABT-199 After Ibrutinib Therapy: Expansion Cohort		ABT-199 After Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib or Idelalisib Therapy: Expansion Cohort		ABT-199 After Ibrutinib Therapy: Main and Expansion Cohorts		ABT-199 After Idelalisib Therapy: Main and Expansion Cohorts		All Participants
	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	43/43 (100.00%)		21/21 (100.00%)		64/64 (100.00%)		48/48 (100.00%)		15/15 (100.00%)		63/63 (100.00%)		91/91 (100.00%)		36/36 (100.00%)		127/127 (100.00%)
Blood and lymphatic system disorders
ANAEMIA † 1	24/43 (55.81%)	44	4/21 (19.05%)	25	28/64 (43.75%)	69	21/48 (43.75%)	51	3/15 (20.00%)	3	24/63 (38.10%)	54	45/91 (49.45%)	95	7/36 (19.44%)	28	52/127 (40.94%)	123
LYMPH NODE PAIN † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	3/91 (3.30%)	3	1/36 (2.78%)	1	4/127 (3.15%)	4
NEUTROPENIA † 1	16/43 (37.21%)	32	10/21 (47.62%)	27	26/64 (40.63%)	59	20/48 (41.67%)	44	9/15 (60.00%)	15	29/63 (46.03%)	59	36/91 (39.56%)	76	19/36 (52.78%)	42	55/127 (43.31%)	118
THROMBOCYTOPENIA † 1	11/43 (25.58%)	14	6/21 (28.57%)	24	17/64 (26.56%)	38	14/48 (29.17%)	25	4/15 (26.67%)	7	18/63 (28.57%)	32	25/91 (27.47%)	39	10/36 (27.78%)	31	35/127 (27.56%)	70
Gastrointestinal disorders
ABDOMINAL DISCOMFORT † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	1/48 (2.08%)	1	1/15 (6.67%)	1	2/63 (3.17%)	2	4/91 (4.40%)	4	2/36 (5.56%)	2	6/127 (4.72%)	6
ABDOMINAL DISTENSION † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	5/48 (10.42%)	5	2/15 (13.33%)	2	7/63 (11.11%)	7	8/91 (8.79%)	8	2/36 (5.56%)	2	10/127 (7.87%)	10
ABDOMINAL PAIN † 1	7/43 (16.28%)	10	0/21 (0.00%)	0	7/64 (10.94%)	10	13/48 (27.08%)	16	3/15 (20.00%)	5	16/63 (25.40%)	21	20/91 (21.98%)	26	3/36 (8.33%)	5	23/127 (18.11%)	31
ABDOMINAL PAIN UPPER † 1	1/43 (2.33%)	2	1/21 (4.76%)	1	2/64 (3.13%)	3	3/48 (6.25%)	3	3/15 (20.00%)	4	6/63 (9.52%)	7	4/91 (4.40%)	5	4/36 (11.11%)	5	8/127 (6.30%)	10
CONSTIPATION † 1	7/43 (16.28%)	12	7/21 (33.33%)	7	14/64 (21.88%)	19	17/48 (35.42%)	18	3/15 (20.00%)	4	20/63 (31.75%)	22	24/91 (26.37%)	30	10/36 (27.78%)	11	34/127 (26.77%)	41
DIARRHOEA † 1	22/43 (51.16%)	38	9/21 (42.86%)	18	31/64 (48.44%)	56	26/48 (54.17%)	56	8/15 (53.33%)	15	34/63 (53.97%)	71	48/91 (52.75%)	94	17/36 (47.22%)	33	65/127 (51.18%)	127
DRY MOUTH † 1	2/43 (4.65%)	2	3/21 (14.29%)	3	5/64 (7.81%)	5	5/48 (10.42%)	5	0/15 (0.00%)	0	5/63 (7.94%)	5	7/91 (7.69%)	7	3/36 (8.33%)	3	10/127 (7.87%)	10
DYSPEPSIA † 1	3/43 (6.98%)	3	1/21 (4.76%)	2	4/64 (6.25%)	5	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	4/91 (4.40%)	4	1/36 (2.78%)	2	5/127 (3.94%)	6
DYSPHAGIA † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	4/91 (4.40%)	4	0/36 (0.00%)	0	4/127 (3.15%)	4
FLATULENCE † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	6/91 (6.59%)	6	2/36 (5.56%)	2	8/127 (6.30%)	8
GASTROOESOPHAGEAL REFLUX DISEASE † 1	4/43 (9.30%)	4	3/21 (14.29%)	3	7/64 (10.94%)	7	5/48 (10.42%)	5	1/15 (6.67%)	1	6/63 (9.52%)	6	9/91 (9.89%)	9	4/36 (11.11%)	4	13/127 (10.24%)	13
HAEMORRHOIDS † 1	4/43 (9.30%)	4	0/21 (0.00%)	0	4/64 (6.25%)	4	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	4/91 (4.40%)	4	0/36 (0.00%)	0	4/127 (3.15%)	4
LARGE INTESTINE POLYP † 1	1/43 (2.33%)	1	2/21 (9.52%)	3	3/64 (4.69%)	4	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	2/91 (2.20%)	2	2/36 (5.56%)	3	4/127 (3.15%)	5
NAUSEA † 1	24/43 (55.81%)	32	6/21 (28.57%)	9	30/64 (46.88%)	41	30/48 (62.50%)	38	4/15 (26.67%)	8	34/63 (53.97%)	46	54/91 (59.34%)	70	10/36 (27.78%)	17	64/127 (50.39%)	87
ORAL PAIN † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	1/48 (2.08%)	1	1/15 (6.67%)	1	2/63 (3.17%)	2	4/91 (4.40%)	4	1/36 (2.78%)	1	5/127 (3.94%)	5
STOMATITIS † 1	4/43 (9.30%)	4	0/21 (0.00%)	0	4/64 (6.25%)	4	5/48 (10.42%)	5	1/15 (6.67%)	1	6/63 (9.52%)	6	9/91 (9.89%)	9	1/36 (2.78%)	1	10/127 (7.87%)	10
TOOTHACHE † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	3/91 (3.30%)	3	0/36 (0.00%)	0	3/127 (2.36%)	3
VOMITING † 1	10/43 (23.26%)	18	3/21 (14.29%)	9	13/64 (20.31%)	27	16/48 (33.33%)	27	0/15 (0.00%)	0	16/63 (25.40%)	27	26/91 (28.57%)	45	3/36 (8.33%)	9	29/127 (22.83%)	54
General disorders
CHILLS † 1	4/43 (9.30%)	4	3/21 (14.29%)	4	7/64 (10.94%)	8	8/48 (16.67%)	9	0/15 (0.00%)	0	8/63 (12.70%)	9	12/91 (13.19%)	13	3/36 (8.33%)	4	15/127 (11.81%)	17
FATIGUE † 1	20/43 (46.51%)	28	7/21 (33.33%)	9	27/64 (42.19%)	37	22/48 (45.83%)	31	3/15 (20.00%)	6	25/63 (39.68%)	37	42/91 (46.15%)	59	10/36 (27.78%)	15	52/127 (40.94%)	74
INFLUENZA LIKE ILLNESS † 1	1/43 (2.33%)	2	3/21 (14.29%)	3	4/64 (6.25%)	5	5/48 (10.42%)	5	0/15 (0.00%)	0	5/63 (7.94%)	5	6/91 (6.59%)	7	3/36 (8.33%)	3	9/127 (7.09%)	10
NON-CARDIAC CHEST PAIN † 1	0/43 (0.00%)	0	1/21 (4.76%)	1	1/64 (1.56%)	1	4/48 (8.33%)	4	0/15 (0.00%)	0	4/63 (6.35%)	4	4/91 (4.40%)	4	1/36 (2.78%)	1	5/127 (3.94%)	5
OEDEMA † 1	0/43 (0.00%)	0	2/21 (9.52%)	2	2/64 (3.13%)	2	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
OEDEMA PERIPHERAL † 1	8/43 (18.60%)	8	6/21 (28.57%)	8	14/64 (21.88%)	16	18/48 (37.50%)	19	1/15 (6.67%)	2	19/63 (30.16%)	21	26/91 (28.57%)	27	7/36 (19.44%)	10	33/127 (25.98%)	37
PAIN † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	6/91 (6.59%)	6	2/36 (5.56%)	2	8/127 (6.30%)	8
PERIPHERAL SWELLING † 1	1/43 (2.33%)	1	3/21 (14.29%)	3	4/64 (6.25%)	4	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	3/91 (3.30%)	3	4/36 (11.11%)	4	7/127 (5.51%)	7
PYREXIA † 1	5/43 (11.63%)	6	3/21 (14.29%)	3	8/64 (12.50%)	9	11/48 (22.92%)	18	2/15 (13.33%)	2	13/63 (20.63%)	20	16/91 (17.58%)	24	5/36 (13.89%)	5	21/127 (16.54%)	29
Hepatobiliary disorders
HYPERBILIRUBINAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	4/48 (8.33%)	4	1/15 (6.67%)	1	5/63 (7.94%)	5	4/91 (4.40%)	4	1/36 (2.78%)	1	5/127 (3.94%)	5
Immune system disorders
SEASONAL ALLERGY † 1	0/43 (0.00%)	0	2/21 (9.52%)	2	2/64 (3.13%)	2	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	0/91 (0.00%)	0	2/36 (5.56%)	2	2/127 (1.57%)	2
Infections and infestations
BRONCHITIS † 1	2/43 (4.65%)	2	1/21 (4.76%)	1	3/64 (4.69%)	3	4/48 (8.33%)	5	3/15 (20.00%)	4	7/63 (11.11%)	9	6/91 (6.59%)	7	4/36 (11.11%)	5	10/127 (7.87%)	12
CELLULITIS † 1	2/43 (4.65%)	2	3/21 (14.29%)	4	5/64 (7.81%)	6	3/48 (6.25%)	4	0/15 (0.00%)	0	3/63 (4.76%)	4	5/91 (5.49%)	6	3/36 (8.33%)	4	8/127 (6.30%)	10
CONJUNCTIVITIS † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	1/48 (2.08%)	1	1/15 (6.67%)	1	2/63 (3.17%)	2	2/91 (2.20%)	2	3/36 (8.33%)	3	5/127 (3.94%)	5
HERPES ZOSTER † 1	1/43 (2.33%)	1	2/21 (9.52%)	3	3/64 (4.69%)	4	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	3/91 (3.30%)	3	2/36 (5.56%)	3	5/127 (3.94%)	6
INFLUENZA † 1	5/43 (11.63%)	5	3/21 (14.29%)	4	8/64 (12.50%)	9	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	8/91 (8.79%)	8	4/36 (11.11%)	5	12/127 (9.45%)	13
NASOPHARYNGITIS † 1	5/43 (11.63%)	5	1/21 (4.76%)	1	6/64 (9.38%)	6	2/48 (4.17%)	2	1/15 (6.67%)	2	3/63 (4.76%)	4	7/91 (7.69%)	7	2/36 (5.56%)	3	9/127 (7.09%)	10
ORAL CANDIDIASIS † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	1/48 (2.08%)	2	0/15 (0.00%)	0	1/63 (1.59%)	2	2/91 (2.20%)	3	2/36 (5.56%)	2	4/127 (3.15%)	5
PNEUMONIA † 1	4/43 (9.30%)	4	3/21 (14.29%)	3	7/64 (10.94%)	7	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	6/91 (6.59%)	6	4/36 (11.11%)	4	10/127 (7.87%)	10
SINUSITIS † 1	2/43 (4.65%)	2	1/21 (4.76%)	1	3/64 (4.69%)	3	6/48 (12.50%)	7	3/15 (20.00%)	5	9/63 (14.29%)	12	8/91 (8.79%)	9	4/36 (11.11%)	6	12/127 (9.45%)	15
UPPER RESPIRATORY TRACT INFECTION † 1	15/43 (34.88%)	29	9/21 (42.86%)	15	24/64 (37.50%)	44	19/48 (39.58%)	37	7/15 (46.67%)	16	26/63 (41.27%)	53	34/91 (37.36%)	66	16/36 (44.44%)	31	50/127 (39.37%)	97
URINARY TRACT INFECTION † 1	2/43 (4.65%)	5	2/21 (9.52%)	8	4/64 (6.25%)	13	9/48 (18.75%)	17	0/15 (0.00%)	0	9/63 (14.29%)	17	11/91 (12.09%)	22	2/36 (5.56%)	8	13/127 (10.24%)	30
Injury, poisoning and procedural complications
CONTUSION † 1	10/43 (23.26%)	11	2/21 (9.52%)	2	12/64 (18.75%)	13	9/48 (18.75%)	10	1/15 (6.67%)	1	10/63 (15.87%)	11	19/91 (20.88%)	21	3/36 (8.33%)	3	22/127 (17.32%)	24
FALL † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	4/48 (8.33%)	6	1/15 (6.67%)	1	5/63 (7.94%)	7	7/91 (7.69%)	9	2/36 (5.56%)	2	9/127 (7.09%)	11
SKIN ABRASION † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	4/48 (8.33%)	5	0/15 (0.00%)	0	4/63 (6.35%)	5	5/91 (5.49%)	6	0/36 (0.00%)	0	5/127 (3.94%)	6
SKIN LACERATION † 1	2/43 (4.65%)	2	2/21 (9.52%)	2	4/64 (6.25%)	4	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	4/91 (4.40%)	4	3/36 (8.33%)	3	7/127 (5.51%)	7
Investigations
ALANINE AMINOTRANSFERASE INCREASED † 1	6/43 (13.95%)	8	2/21 (9.52%)	7	8/64 (12.50%)	15	8/48 (16.67%)	8	0/15 (0.00%)	0	8/63 (12.70%)	8	14/91 (15.38%)	16	2/36 (5.56%)	7	16/127 (12.60%)	23
ASPARTATE AMINOTRANSFERASE INCREASED † 1	10/43 (23.26%)	13	2/21 (9.52%)	3	12/64 (18.75%)	16	8/48 (16.67%)	9	2/15 (13.33%)	6	10/63 (15.87%)	15	18/91 (19.78%)	22	4/36 (11.11%)	9	22/127 (17.32%)	31
BLOOD ALKALINE PHOSPHATASE INCREASED † 1	4/43 (9.30%)	4	2/21 (9.52%)	4	6/64 (9.38%)	8	5/48 (10.42%)	5	2/15 (13.33%)	4	7/63 (11.11%)	9	9/91 (9.89%)	9	4/36 (11.11%)	8	13/127 (10.24%)	17
BLOOD BILIRUBIN INCREASED † 1	4/43 (9.30%)	4	3/21 (14.29%)	3	7/64 (10.94%)	7	8/48 (16.67%)	12	2/15 (13.33%)	2	10/63 (15.87%)	14	12/91 (13.19%)	16	5/36 (13.89%)	5	17/127 (13.39%)	21
BLOOD CHOLESTEROL INCREASED † 1	0/43 (0.00%)	0	2/21 (9.52%)	2	2/64 (3.13%)	2	2/48 (4.17%)	3	0/15 (0.00%)	0	2/63 (3.17%)	3	2/91 (2.20%)	3	2/36 (5.56%)	2	4/127 (3.15%)	5
BLOOD CREATININE INCREASED † 1	2/43 (4.65%)	3	2/21 (9.52%)	3	4/64 (6.25%)	6	6/48 (12.50%)	10	3/15 (20.00%)	7	9/63 (14.29%)	17	8/91 (8.79%)	13	5/36 (13.89%)	10	13/127 (10.24%)	23
LYMPHOCYTE COUNT DECREASED † 1	12/43 (27.91%)	28	2/21 (9.52%)	2	14/64 (21.88%)	30	12/48 (25.00%)	27	1/15 (6.67%)	1	13/63 (20.63%)	28	24/91 (26.37%)	55	3/36 (8.33%)	3	27/127 (21.26%)	58
LYMPHOCYTE COUNT INCREASED † 1	6/43 (13.95%)	10	0/21 (0.00%)	0	6/64 (9.38%)	10	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	8/91 (8.79%)	12	0/36 (0.00%)	0	8/127 (6.30%)	12
NEUTROPHIL COUNT DECREASED † 1	20/43 (46.51%)	60	1/21 (4.76%)	1	21/64 (32.81%)	61	12/48 (25.00%)	48	2/15 (13.33%)	2	14/63 (22.22%)	50	32/91 (35.16%)	108	3/36 (8.33%)	3	35/127 (27.56%)	111
PLATELET COUNT DECREASED † 1	19/43 (44.19%)	35	1/21 (4.76%)	1	20/64 (31.25%)	36	11/48 (22.92%)	23	4/15 (26.67%)	6	15/63 (23.81%)	29	30/91 (32.97%)	58	5/36 (13.89%)	7	35/127 (27.56%)	65
WEIGHT DECREASED † 1	4/43 (9.30%)	6	1/21 (4.76%)	1	5/64 (7.81%)	7	6/48 (12.50%)	6	0/15 (0.00%)	0	6/63 (9.52%)	6	10/91 (10.99%)	12	1/36 (2.78%)	1	11/127 (8.66%)	13
WEIGHT INCREASED † 1	3/43 (6.98%)	3	1/21 (4.76%)	1	4/64 (6.25%)	4	5/48 (10.42%)	7	1/15 (6.67%)	1	6/63 (9.52%)	8	8/91 (8.79%)	10	2/36 (5.56%)	2	10/127 (7.87%)	12
WHITE BLOOD CELL COUNT DECREASED † 1	18/43 (41.86%)	40	2/21 (9.52%)	6	20/64 (31.25%)	46	16/48 (33.33%)	64	3/15 (20.00%)	4	19/63 (30.16%)	68	34/91 (37.36%)	104	5/36 (13.89%)	10	39/127 (30.71%)	114
Metabolism and nutrition disorders
DECREASED APPETITE † 1	5/43 (11.63%)	5	3/21 (14.29%)	3	8/64 (12.50%)	8	3/48 (6.25%)	3	3/15 (20.00%)	3	6/63 (9.52%)	6	8/91 (8.79%)	8	6/36 (16.67%)	6	14/127 (11.02%)	14
DEHYDRATION † 1	5/43 (11.63%)	6	2/21 (9.52%)	2	7/64 (10.94%)	8	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	7/91 (7.69%)	8	3/36 (8.33%)	3	10/127 (7.87%)	11
HYPERGLYCAEMIA † 1	3/43 (6.98%)	4	3/21 (14.29%)	8	6/64 (9.38%)	12	7/48 (14.58%)	18	0/15 (0.00%)	0	7/63 (11.11%)	18	10/91 (10.99%)	22	3/36 (8.33%)	8	13/127 (10.24%)	30
HYPERKALAEMIA † 1	7/43 (16.28%)	9	1/21 (4.76%)	2	8/64 (12.50%)	11	6/48 (12.50%)	11	2/15 (13.33%)	3	8/63 (12.70%)	14	13/91 (14.29%)	20	3/36 (8.33%)	5	16/127 (12.60%)	25
HYPERNATRAEMIA † 1	0/43 (0.00%)	0	0/21 (0.00%)	0	0/64 (0.00%)	0	4/48 (8.33%)	5	0/15 (0.00%)	0	4/63 (6.35%)	5	4/91 (4.40%)	5	0/36 (0.00%)	0	4/127 (3.15%)	5
HYPERPHOSPHATAEMIA † 1	7/43 (16.28%)	9	6/21 (28.57%)	8	13/64 (20.31%)	17	4/48 (8.33%)	7	1/15 (6.67%)	1	5/63 (7.94%)	8	11/91 (12.09%)	16	7/36 (19.44%)	9	18/127 (14.17%)	25
HYPERURICAEMIA † 1	10/43 (23.26%)	22	4/21 (19.05%)	7	14/64 (21.88%)	29	4/48 (8.33%)	5	2/15 (13.33%)	6	6/63 (9.52%)	11	14/91 (15.38%)	27	6/36 (16.67%)	13	20/127 (15.75%)	40
HYPOALBUMINAEMIA † 1	6/43 (13.95%)	10	1/21 (4.76%)	3	7/64 (10.94%)	13	10/48 (20.83%)	20	2/15 (13.33%)	6	12/63 (19.05%)	26	16/91 (17.58%)	30	3/36 (8.33%)	9	19/127 (14.96%)	39
HYPOCALCAEMIA † 1	9/43 (20.93%)	17	3/21 (14.29%)	6	12/64 (18.75%)	23	14/48 (29.17%)	28	3/15 (20.00%)	5	17/63 (26.98%)	33	23/91 (25.27%)	45	6/36 (16.67%)	11	29/127 (22.83%)	56
HYPOKALAEMIA † 1	11/43 (25.58%)	15	5/21 (23.81%)	11	16/64 (25.00%)	26	13/48 (27.08%)	25	4/15 (26.67%)	9	17/63 (26.98%)	34	24/91 (26.37%)	40	9/36 (25.00%)	20	33/127 (25.98%)	60
HYPOMAGNESAEMIA † 1	10/43 (23.26%)	17	1/21 (4.76%)	1	11/64 (17.19%)	18	14/48 (29.17%)	16	3/15 (20.00%)	4	17/63 (26.98%)	20	24/91 (26.37%)	33	4/36 (11.11%)	5	28/127 (22.05%)	38
HYPONATRAEMIA † 1	12/43 (27.91%)	16	2/21 (9.52%)	3	14/64 (21.88%)	19	7/48 (14.58%)	12	2/15 (13.33%)	4	9/63 (14.29%)	16	19/91 (20.88%)	28	4/36 (11.11%)	7	23/127 (18.11%)	35
HYPOPHOSPHATAEMIA † 1	6/43 (13.95%)	10	3/21 (14.29%)	3	9/64 (14.06%)	13	12/48 (25.00%)	17	4/15 (26.67%)	7	16/63 (25.40%)	24	18/91 (19.78%)	27	7/36 (19.44%)	10	25/127 (19.69%)	37
Musculoskeletal and connective tissue disorders
ARTHRALGIA † 1	5/43 (11.63%)	7	3/21 (14.29%)	3	8/64 (12.50%)	10	15/48 (31.25%)	31	3/15 (20.00%)	5	18/63 (28.57%)	36	20/91 (21.98%)	38	6/36 (16.67%)	8	26/127 (20.47%)	46
ARTHRITIS † 1	3/43 (6.98%)	4	0/21 (0.00%)	0	3/64 (4.69%)	4	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	5/91 (5.49%)	6	1/36 (2.78%)	1	6/127 (4.72%)	7
BACK PAIN † 1	8/43 (18.60%)	8	4/21 (19.05%)	4	12/64 (18.75%)	12	10/48 (20.83%)	16	3/15 (20.00%)	3	13/63 (20.63%)	19	18/91 (19.78%)	24	7/36 (19.44%)	7	25/127 (19.69%)	31
BONE PAIN † 1	3/43 (6.98%)	4	0/21 (0.00%)	0	3/64 (4.69%)	4	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	5/91 (5.49%)	6	1/36 (2.78%)	1	6/127 (4.72%)	7
MUSCLE SPASMS † 1	5/43 (11.63%)	5	5/21 (23.81%)	5	10/64 (15.63%)	10	4/48 (8.33%)	5	1/15 (6.67%)	1	5/63 (7.94%)	6	9/91 (9.89%)	10	6/36 (16.67%)	6	15/127 (11.81%)	16
MUSCLE TIGHTNESS † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
MYALGIA † 1	4/43 (9.30%)	4	1/21 (4.76%)	4	5/64 (7.81%)	8	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	7/91 (7.69%)	7	2/36 (5.56%)	5	9/127 (7.09%)	12
PAIN IN EXTREMITY † 1	6/43 (13.95%)	6	4/21 (19.05%)	5	10/64 (15.63%)	11	9/48 (18.75%)	11	4/15 (26.67%)	4	13/63 (20.63%)	15	15/91 (16.48%)	17	8/36 (22.22%)	9	23/127 (18.11%)	26
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BASAL CELL CARCINOMA † 1	3/43 (6.98%)	3	2/21 (9.52%)	2	5/64 (7.81%)	5	4/48 (8.33%)	5	2/15 (13.33%)	2	6/63 (9.52%)	7	7/91 (7.69%)	8	4/36 (11.11%)	4	11/127 (8.66%)	12
SQUAMOUS CELL CARCINOMA OF SKIN † 1	2/43 (4.65%)	5	1/21 (4.76%)	1	3/64 (4.69%)	6	4/48 (8.33%)	6	2/15 (13.33%)	2	6/63 (9.52%)	8	6/91 (6.59%)	11	3/36 (8.33%)	3	9/127 (7.09%)	14
Nervous system disorders
DIZZINESS † 1	6/43 (13.95%)	8	1/21 (4.76%)	1	7/64 (10.94%)	9	13/48 (27.08%)	14	4/15 (26.67%)	4	17/63 (26.98%)	18	19/91 (20.88%)	22	5/36 (13.89%)	5	24/127 (18.90%)	27
HEADACHE † 1	12/43 (27.91%)	14	4/21 (19.05%)	6	16/64 (25.00%)	20	15/48 (31.25%)	24	2/15 (13.33%)	2	17/63 (26.98%)	26	27/91 (29.67%)	38	6/36 (16.67%)	8	33/127 (25.98%)	46
HYPOAESTHESIA † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	6/91 (6.59%)	6	1/36 (2.78%)	1	7/127 (5.51%)	7
PARAESTHESIA † 1	2/43 (4.65%)	2	2/21 (9.52%)	3	4/64 (6.25%)	5	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	2/91 (2.20%)	2	3/36 (8.33%)	4	5/127 (3.94%)	6
PERIPHERAL SENSORY NEUROPATHY † 1	1/43 (2.33%)	1	0/21 (0.00%)	0	1/64 (1.56%)	1	4/48 (8.33%)	5	1/15 (6.67%)	1	5/63 (7.94%)	6	5/91 (5.49%)	6	1/36 (2.78%)	1	6/127 (4.72%)	7
Psychiatric disorders
ANXIETY † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
DEPRESSION † 1	1/43 (2.33%)	1	2/21 (9.52%)	3	3/64 (4.69%)	4	3/48 (6.25%)	3	2/15 (13.33%)	2	5/63 (7.94%)	5	4/91 (4.40%)	4	4/36 (11.11%)	5	8/127 (6.30%)	9
INSOMNIA † 1	3/43 (6.98%)	5	6/21 (28.57%)	6	9/64 (14.06%)	11	10/48 (20.83%)	10	2/15 (13.33%)	2	12/63 (19.05%)	12	13/91 (14.29%)	15	8/36 (22.22%)	8	21/127 (16.54%)	23
Renal and urinary disorders
ACUTE KIDNEY INJURY † 1	4/43 (9.30%)	4	2/21 (9.52%)	2	6/64 (9.38%)	6	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	6/91 (6.59%)	6	3/36 (8.33%)	3	9/127 (7.09%)	9
BLADDER SPASM † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
POLLAKIURIA † 1	2/43 (4.65%)	2	3/21 (14.29%)	3	5/64 (7.81%)	5	3/48 (6.25%)	3	1/15 (6.67%)	1	4/63 (6.35%)	4	5/91 (5.49%)	5	4/36 (11.11%)	4	9/127 (7.09%)	9
Reproductive system and breast disorders
ERECTILE DYSFUNCTION † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	3/91 (3.30%)	3	0/36 (0.00%)	0	3/127 (2.36%)	3
Respiratory, thoracic and mediastinal disorders
COUGH † 1	14/43 (32.56%)	18	4/21 (19.05%)	5	18/64 (28.13%)	23	13/48 (27.08%)	17	5/15 (33.33%)	7	18/63 (28.57%)	24	27/91 (29.67%)	35	9/36 (25.00%)	12	36/127 (28.35%)	47
DYSPNOEA † 1	13/43 (30.23%)	17	3/21 (14.29%)	3	16/64 (25.00%)	20	7/48 (14.58%)	9	3/15 (20.00%)	3	10/63 (15.87%)	12	20/91 (21.98%)	26	6/36 (16.67%)	6	26/127 (20.47%)	32
EPISTAXIS † 1	4/43 (9.30%)	5	0/21 (0.00%)	0	4/64 (6.25%)	5	6/48 (12.50%)	7	0/15 (0.00%)	0	6/63 (9.52%)	7	10/91 (10.99%)	12	0/36 (0.00%)	0	10/127 (7.87%)	12
NASAL CONGESTION † 1	6/43 (13.95%)	7	4/21 (19.05%)	5	10/64 (15.63%)	12	2/48 (4.17%)	2	1/15 (6.67%)	1	3/63 (4.76%)	3	8/91 (8.79%)	9	5/36 (13.89%)	6	13/127 (10.24%)	15
OROPHARYNGEAL PAIN † 1	6/43 (13.95%)	6	1/21 (4.76%)	1	7/64 (10.94%)	7	7/48 (14.58%)	10	1/15 (6.67%)	1	8/63 (12.70%)	11	13/91 (14.29%)	16	2/36 (5.56%)	2	15/127 (11.81%)	18
RHINITIS ALLERGIC † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	4/48 (8.33%)	6	1/15 (6.67%)	1	5/63 (7.94%)	7	7/91 (7.69%)	9	1/36 (2.78%)	1	8/127 (6.30%)	10
RHINORRHOEA † 1	1/43 (2.33%)	1	4/21 (19.05%)	4	5/64 (7.81%)	5	2/48 (4.17%)	4	2/15 (13.33%)	2	4/63 (6.35%)	6	3/91 (3.30%)	5	6/36 (16.67%)	6	9/127 (7.09%)	11
SINUS CONGESTION † 1	3/43 (6.98%)	4	0/21 (0.00%)	0	3/64 (4.69%)	4	0/48 (0.00%)	0	1/15 (6.67%)	1	1/63 (1.59%)	1	3/91 (3.30%)	4	1/36 (2.78%)	1	4/127 (3.15%)	5
UPPER-AIRWAY COUGH SYNDROME † 1	3/43 (6.98%)	5	2/21 (9.52%)	2	5/64 (7.81%)	7	6/48 (12.50%)	6	0/15 (0.00%)	0	6/63 (9.52%)	6	9/91 (9.89%)	11	2/36 (5.56%)	2	11/127 (8.66%)	13
WHEEZING † 1	2/43 (4.65%)	4	2/21 (9.52%)	2	4/64 (6.25%)	6	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	4/91 (4.40%)	6	2/36 (5.56%)	2	6/127 (4.72%)	8
Skin and subcutaneous tissue disorders
ACTINIC KERATOSIS † 1	4/43 (9.30%)	5	2/21 (9.52%)	2	6/64 (9.38%)	7	1/48 (2.08%)	1	0/15 (0.00%)	0	1/63 (1.59%)	1	5/91 (5.49%)	6	2/36 (5.56%)	2	7/127 (5.51%)	8
DRY SKIN † 1	3/43 (6.98%)	5	0/21 (0.00%)	0	3/64 (4.69%)	5	3/48 (6.25%)	4	0/15 (0.00%)	0	3/63 (4.76%)	4	6/91 (6.59%)	9	0/36 (0.00%)	0	6/127 (4.72%)	9
ECZEMA † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	3/91 (3.30%)	3	2/36 (5.56%)	2	5/127 (3.94%)	5
HAIR COLOUR CHANGES † 1	1/43 (2.33%)	1	2/21 (9.52%)	2	3/64 (4.69%)	3	0/48 (0.00%)	0	0/15 (0.00%)	0	0/63 (0.00%)	0	1/91 (1.10%)	1	2/36 (5.56%)	2	3/127 (2.36%)	3
HYPERHIDROSIS † 1	4/43 (9.30%)	4	1/21 (4.76%)	1	5/64 (7.81%)	5	3/48 (6.25%)	3	0/15 (0.00%)	0	3/63 (4.76%)	3	7/91 (7.69%)	7	1/36 (2.78%)	1	8/127 (6.30%)	8
NIGHT SWEATS † 1	5/43 (11.63%)	6	0/21 (0.00%)	0	5/64 (7.81%)	6	6/48 (12.50%)	6	0/15 (0.00%)	0	6/63 (9.52%)	6	11/91 (12.09%)	12	0/36 (0.00%)	0	11/127 (8.66%)	12
PRURITUS † 1	4/43 (9.30%)	5	4/21 (19.05%)	6	8/64 (12.50%)	11	1/48 (2.08%)	1	2/15 (13.33%)	2	3/63 (4.76%)	3	5/91 (5.49%)	6	6/36 (16.67%)	8	11/127 (8.66%)	14
RASH † 1	8/43 (18.60%)	8	6/21 (28.57%)	12	14/64 (21.88%)	20	6/48 (12.50%)	7	3/15 (20.00%)	4	9/63 (14.29%)	11	14/91 (15.38%)	15	9/36 (25.00%)	16	23/127 (18.11%)	31
SKIN LESION † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	5/91 (5.49%)	5	0/36 (0.00%)	0	5/127 (3.94%)	5
SKIN ULCER † 1	3/43 (6.98%)	3	0/21 (0.00%)	0	3/64 (4.69%)	3	2/48 (4.17%)	2	0/15 (0.00%)	0	2/63 (3.17%)	2	5/91 (5.49%)	5	0/36 (0.00%)	0	5/127 (3.94%)	5
Vascular disorders
HYPERTENSION † 1	7/43 (16.28%)	12	3/21 (14.29%)	3	10/64 (15.63%)	15	11/48 (22.92%)	15	4/15 (26.67%)	7	15/63 (23.81%)	22	18/91 (19.78%)	27	7/36 (19.44%)	10	25/127 (19.69%)	37
1 Term from vocabulary, MedDRA 24.1; † 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.

AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.

Results Point of Contact

• Name/Title: Global Medical Services
• Organization: AbbVie
• Phone: 800-633-9110
• EMail: abbvieclinicaltrials@abbvie.com

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

Roberts AW, Ma S, Kipps TJ, Coutre SE, Davids MS, Eichhorst B, Hallek M, Byrd JC, Humphrey K, Zhou L, Chyla B, Nielsen J, Potluri J, Kim SY, Verdugo M, Stilgenbauer S, Wierda WG, Seymour JF. Efficacy of venetoclax in relapsed chronic lymphocytic leukemia is influenced by disease and response variables. Blood. 2019 Jul 11;134(2):111-122. doi: 10.1182/blood.2018882555. Epub 2019 Apr 25.

Coutre S, Choi M, Furman RR, Eradat H, Heffner L, Jones JA, Chyla B, Zhou L, Agarwal S, Waskiewicz T, Verdugo M, Humerickhouse RA, Potluri J, Wierda WG, Davids MS. Venetoclax for patients with chronic lymphocytic leukemia who progressed during or after idelalisib therapy. Blood. 2018 Apr 12;131(15):1704-1711. doi: 10.1182/blood-2017-06-788133. Epub 2018 Jan 5.

Jones JA, Mato AR, Wierda WG, Davids MS, Choi M, Cheson BD, Furman RR, Lamanna N, Barr PM, Zhou L, Chyla B, Salem AH, Verdugo M, Humerickhouse RA, Potluri J, Coutre S, Woyach J, Byrd JC. Venetoclax for chronic lymphocytic leukaemia progressing after ibrutinib: an interim analysis of a multicentre, open-label, phase 2 trial. Lancet Oncol. 2018 Jan;19(1):65-75. doi: 10.1016/S1470-2045(17)30909-9. Epub 2017 Dec 12.

• Responsible Party: AbbVie
• ClinicalTrials.gov Identifier: NCT02141282
• Other Study ID Numbers: M14-032
• First Submitted: May 12, 2014
• First Posted: May 19, 2014
• Results First Submitted: November 18, 2022
• Results First Posted: December 19, 2022
• Last Update Posted: December 19, 2022