Trial Outcomes & Findings for Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma (NCT NCT03117309)

Last Updated: 2025-07-10

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. 1-year Progression-Free Survival (PFS) Rate refers to the percentage of patients who have not experienced disease progression or death from any cause within one year of starting treatment. The 1-year PFS rate of nivolumab in treatment-naïve patients with clear cell renal cell carcinoma (ccRCC) was assessed according to tumor PD-L1 expression levels.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

164 participants

Primary outcome timeframe

1 year

Results posted on

2025-07-10

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4. Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Overall Study STARTED	128	36
Overall Study COMPLETED	128	35
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4. Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Overall Study Not meeting inclusion criteria	0	1

Baseline Characteristics

Study of Front Line Therapy With Nivolumab and Salvage Nivolumab + Ipilimumab in Patients With Advanced Renal Cell Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A: Nivolumab and Salvage Nivolumab/Ipilimumab in Clear Cell RCC n=128 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4. Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC n=35 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Total n=163 Participants Total of all reporting groups
Age, Continuous	65 years n=39 Participants	63 years n=41 Participants	64 years n=35 Participants
Sex: Female, Male Female	36 Participants n=39 Participants	4 Participants n=41 Participants	40 Participants n=35 Participants
Sex: Female, Male Male	92 Participants n=39 Participants	31 Participants n=41 Participants	123 Participants n=35 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=39 Participants	0 Participants n=41 Participants	7 Participants n=35 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	120 Participants n=39 Participants	34 Participants n=41 Participants	154 Participants n=35 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants	1 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=39 Participants	0 Participants n=41 Participants	2 Participants n=35 Participants
Race (NIH/OMB) Asian	4 Participants n=39 Participants	1 Participants n=41 Participants	5 Participants n=35 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Race (NIH/OMB) Black or African American	12 Participants n=39 Participants	8 Participants n=41 Participants	20 Participants n=35 Participants
Race (NIH/OMB) White	107 Participants n=39 Participants	25 Participants n=41 Participants	132 Participants n=35 Participants
Race (NIH/OMB) More than one race	1 Participants n=39 Participants	0 Participants n=41 Participants	1 Participants n=35 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=39 Participants	1 Participants n=41 Participants	3 Participants n=35 Participants
Region of Enrollment United States	128 participants n=39 Participants	35 participants n=41 Participants	163 participants n=35 Participants
ECOG Performance Status ECOG = 0	81 participants n=39 Participants	16 participants n=41 Participants	97 participants n=35 Participants
ECOG Performance Status ECOG = 1	46 participants n=39 Participants	17 participants n=41 Participants	63 participants n=35 Participants
ECOG Performance Status ECOG = 2	1 participants n=39 Participants	2 participants n=41 Participants	3 participants n=35 Participants

PRIMARY outcome

Timeframe: 1 year

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for ccRCC patients was defined as all patients treated with nivolumab and has PD-L1 expression.

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=102 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
1-year Progression Free Survival (PFS) Rate for ccRCC Patients PD-L1 0%	34.6 Percentage of participants Interval 24.3 to 45.1	—
1-year Progression Free Survival (PFS) Rate for ccRCC Patients PD-L1 1-5%	53.8 Percentage of participants Interval 24.8 to 76.0	—
1-year Progression Free Survival (PFS) Rate for ccRCC Patients PD-L1 5-20%	33.3 Percentage of participants Interval 0.9 to 77.4	—
1-year Progression Free Survival (PFS) Rate for ccRCC Patients PD-L1 > 20%	75 Percentage of participants Interval 31.5 to 93.1	—

SECONDARY outcome

Timeframe: Up to 39 Months

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR Evaluate ORR for nivolumab in patients with treatment naïve clear cell renal cell carcinoma (ccRCC) based on PD-L1 expression.

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=102 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy PD-L1 0%	26.9 Percentage of participants Interval 17.5 to 38.2	—
Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy PD-L1 1-5%	53.8 Percentage of participants Interval 25.1 to 80.8	—
Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy PD-L1 5-20%	33.3 Percentage of participants Interval 0.8 to 90.6	—
Objective Response Rate for ccRCC Patients Treated With Nivolumab Monotherapy PD-L1 > 20%	75 Percentage of participants Interval 34.9 to 96.8	—

SECONDARY outcome

Timeframe: Up to 39 Months

Population: In accordance with the Statistical Analysis Plan, the analysis population for the endpoint progression-free survival for Part B (treated with Nivolumab and Ipilimumab) ccRCC patients was defined as all patients who entered Part B and had PD-L1 expression.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD) \>= 20% increase in tumor burden relative to nadir or the appearance of one or more new lesions; Stable Disease (SD), not meet criteria for CR/PR/PD. ORR = CR +PR. Evaluate ORR in combined nivolumab and ipilimumab therapy at the time of nivolumab failure for ccRCC patients based on PD-L1 expression.

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=30 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab PD-L1 0%	7.7 Percentage of participants Interval 0.9 to 25.1	—
Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab PD-L1 1-5%	66.7 Percentage of participants Interval 9.4 to 99.2	—
Objective Response Rate (ORR) for ccRCC Patients Treated With Nivolumab and Ipilimumab PD-L1 5-20%	0 Percentage of participants Not enough events occur to calculate 95% confidence interval	—

SECONDARY outcome

Timeframe: Up to 39 Months

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=35 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Clinical Activity for nccRCC Patients	60 Percentage of participants	—

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=35 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
1-year Progression Free Survival (PFS) Rate for nccRCC Patients	25.4 Percentage of participants Interval 14.3 to 45.0	—

SECONDARY outcome

Timeframe: Up to 28 months

Adverse events will be assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) version 4.

Outcome measures

Outcome measures
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=128 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B: Nivolumab and Salvage Nivolumab/Ipilimumab in Non-clear Cell RCC n=35 Participants All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Number of Participants With Adverse Events	128 Participants	35 Participants

Adverse Events

Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC

Serious events: 41 serious events

Other events: 127 other events

Deaths: 38 deaths

Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC

Serious events: 19 serious events

Other events: 38 other events

Deaths: 28 deaths

Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC

Serious events: 8 serious events

Other events: 34 other events

Deaths: 11 deaths

Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC

Serious events: 5 serious events

Other events: 17 other events

Deaths: 15 deaths

Serious adverse events

Other adverse events

Additional Information

Fauzia Sharmin

Hoosier Cancer Research Network

Phone: 317-921-2050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Serious adverse events
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=128 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC n=40 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4. Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC n=35 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC n=17 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Nervous system disorders FACIAL NERVE DISORDER	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Injury, poisoning and procedural complications FALL	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
General disorders FEVER	1.6% 2/128 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
General disorders GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS - OTHER, SPECIFY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders HEART FAILURE	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Metabolism and nutrition disorders HYPERCALCEMIA	0.78% 1/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Metabolism and nutrition disorders HYPONATREMIA	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Vascular disorders HYPOTENSION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations INFECTIONS AND INFESTATIONS - OTHER, SPECIFY	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Injury, poisoning and procedural complications INJURY, POISONING AND PROCEDURAL COMPLICATIONS - OTHER, SPECIFY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations LUNG INFECTION	3.1% 4/128 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders MENINGISMUS	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Metabolism and nutrition disorders METABOLISM AND NUTRITION DISORDERS - OTHER, SPECIFY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDER - OTHER, SPECIFY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders MYOCARDIAL INFARCTION	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders MYOCARDITIS	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders NAUSEA	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.6% 2/128 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	1.6% 2/128 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders RETROPERITONEAL HEMORRHAGE	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders SEIZURE	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations SEPSIS	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations SKIN INFECTION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Injury, poisoning and procedural complications SPINAL FRACTURE	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Skin and subcutaneous tissue disorders STEVENS-JOHNSON SYNDROME	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders STROKE	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Vascular disorders THROMBOEMBOLIC EVENT	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders TRANSIENT ISCHEMIC ATTACKS	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations URINARY TRACT INFECTION	1.6% 2/128 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders VOMITING	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders ABDOMINAL PAIN	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations BLOOD BILIRUBIN INCREASED	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations CARDIAC TROPONIN I INCREASED	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Metabolism and nutrition disorders DEHYDRATION	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Hepatobiliary disorders GALLBLADDER OBSTRUCTION	0.00% 0/128 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.

Other adverse events
Measure	Cohort A Part A: Nivolumab Monotherapy in Clear Cell RCC n=128 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment. Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort A Part B: Nivolumab/Ipilimumab in Clear Cell RCC n=40 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4. Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B Part A: Nivolumab Monotherapy in Non-clear Cell RCC n=35 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART A: Nivolumab Nivolumab 240 mg: PART A Nivolumab 240 mg IV every 2 weeks x 6 then initial disease assessment Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks	Cohort B Part B: Nivolumab/Ipilimumab in Non-clear Cell RCC n=17 participants at risk All patients initiated treatment with nivolumab monotherapy (Part A). Those with progressive disease or stable disease at 48 weeks could receive a combination nivolumab/ipilimumab (Part B). PART B: Nivolumab + Ipilimumab Ipilimumab 1mg/kg: Ipilimumab 1 mg/kg every 3 weeks x 4 Nivolumab 3mg/kg: In combination with Ipilimumab Nivolumab 360mg: Continue Nivolumab 360 mg IV every 3 weeks
Infections and infestations ABDOMINAL INFECTION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders ABDOMINAL PAIN	14.8% 19/128 • Number of events 23 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	12.5% 5/40 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	17.1% 6/35 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	23.5% 4/17 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Renal and urinary disorders ACUTE KIDNEY INJURY	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.0% 2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Endocrine disorders ADRENAL INSUFFICIENCY	2.3% 3/128 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	7.5% 3/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Psychiatric disorders AGITATION	2.3% 3/128 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations ALANINE AMINOTRANSFERASE INCREASED	18.0% 23/128 • Number of events 37 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	12.5% 5/40 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	14.3% 5/35 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	11.8% 2/17 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations ALKALINE PHOSPHATASE INCREASED	24.2% 31/128 • Number of events 49 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	12.5% 5/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	22.9% 8/35 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	23.5% 4/17 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Immune system disorders ALLERGIC REACTION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Respiratory, thoracic and mediastinal disorders ALLERGIC RHINITIS	5.5% 7/128 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.0% 2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders AMNESIA	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Blood and lymphatic system disorders ANEMIA	26.6% 34/128 • Number of events 68 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	22.5% 9/40 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	40.0% 14/35 • Number of events 26 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	35.3% 6/17 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Metabolism and nutrition disorders ANOREXIA	10.9% 14/128 • Number of events 17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	22.5% 9/40 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	11.4% 4/35 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	11.8% 2/17 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Psychiatric disorders ANXIETY	7.8% 10/128 • Number of events 12 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	8.6% 3/35 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders ARTHRALGIA	24.2% 31/128 • Number of events 45 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders ARTHRITIS	5.5% 7/128 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	16.4% 21/128 • Number of events 31 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	10.0% 4/40 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	14.3% 5/35 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	17.6% 3/17 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Nervous system disorders ATAXIA	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders ATRIAL FIBRILLATION	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders BACK PAIN	23.4% 30/128 • Number of events 42 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	10.0% 4/40 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	22.9% 8/35 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	41.2% 7/17 • Number of events 7 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders BLOATING	3.9% 5/128 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Blood and lymphatic system disorders BLOOD AND LYMPHATIC SYSTEM DISORDERS - OTHER, SPECIFY	10.9% 14/128 • Number of events 22 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	8.6% 3/35 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	11.8% 2/17 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations BLOOD BILIRUBIN INCREASED	7.0% 9/128 • Number of events 14 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	7.5% 3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Eye disorders BLURRED VISION	3.1% 4/128 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.0% 2/40 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders BONE PAIN	3.1% 4/128 • Number of events 8 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Reproductive system and breast disorders BREAST PAIN	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Infections and infestations BRONCHIAL INFECTION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Respiratory, thoracic and mediastinal disorders BRONCHIAL OBSTRUCTION	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Injury, poisoning and procedural complications BRUISING	3.9% 5/128 • Number of events 5 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders CARDIAC ARREST	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders CARDIAC DISORDERS - OTHER, SPECIFY	3.1% 4/128 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations CARDIAC TROPONIN I INCREASED	0.78% 1/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations CARDIAC TROPONIN T INCREASED	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Eye disorders CATARACT	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Cardiac disorders CHEST PAIN - CARDIAC	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Musculoskeletal and connective tissue disorders CHEST WALL PAIN	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
General disorders CHILLS	5.5% 7/128 • Number of events 11 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	7.5% 3/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/17 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Investigations CHOLESTEROL HIGH	1.6% 2/128 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	0.78% 1/128 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.0% 2/40 • Number of events 3 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.9% 1/35 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 4 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Gastrointestinal disorders COLITIS	3.9% 5/128 • Number of events 9 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	2.5% 1/40 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 2 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.
Psychiatric disorders CONFUSION	2.3% 3/128 • Number of events 6 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/40 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	0.00% 0/35 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.	5.9% 1/17 • Number of events 1 • All-Cause Mortality was monitored up to a maximum of 60 months. Serious Adverse Events and Other (Not Including Serious) Adverse Events were monitored up to 28 months.