Trial Outcomes & Findings for Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer (NCT NCT02912572)

NCT ID: NCT02912572

Last Updated: 2025-07-10

Results Overview

The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 106 participants
• Primary outcome timeframe: Up to 39 months
• Results posted on: 2025-07-10

Participant Flow

Of the 106 participants who enrolled in the study, 5 participants never started treatment and were excluded from the study: two participants were excluded from the intervention due to not re-meeting eligibility parameters prior to treatment initiation, two participants were hospitalized prior to group assignment and never re-screened for the study, and one participant was excluded from the study per provider discretion. Therefore, 101 participants started on study.

Participant milestones

Measure	MSI-H/POLE-Mutated Avelumab Arm Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Talazoparib Combination Arm Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSS Avelumab/Axitinib Combination Arm Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.
Overall Study STARTED	15	16	35	35
Overall Study COMPLETED	15	16	35	35
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Avelumab in Patients With MSS, MSI-H and POLE-mutated Recurrent or Persistent Endometrial Cancer and of Avelumab/Talazoparib and Avelumab/Axitinib in Patients With MSS Recurrent or Persistent Endometrial Cancer

Baseline characteristics by cohort

Measure	MSS Avelumab/Talazoparib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSI-H/POLE-Mutated Avelumab Arm n=15 Participants Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm n=16 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Axitinib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.	Total n=101 Participants Total of all reporting groups
Age, Continuous	67.9 years STANDARD_DEVIATION 8.41 • n=5 Participants	63.2 years STANDARD_DEVIATION 6.98 • n=5 Participants	65.9 years STANDARD_DEVIATION 8.41 • n=7 Participants	65.1 years STANDARD_DEVIATION 9.23 • n=4 Participants	65.9 years STANDARD_DEVIATION 8.81 • n=21 Participants
Age, Customized	68.8 years n=5 Participants	63.7 years n=5 Participants	66.5 years n=7 Participants	65.5 years n=4 Participants	66.1 years n=21 Participants
Sex: Female, Male Female	35 Participants n=5 Participants	15 Participants n=5 Participants	16 Participants n=7 Participants	35 Participants n=4 Participants	101 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	23 Participants n=5 Participants	14 Participants n=5 Participants	13 Participants n=7 Participants	31 Participants n=4 Participants	81 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=5 Participants	1 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=4 Participants	18 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=4 Participants	17 Participants n=21 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants	13 Participants n=5 Participants	13 Participants n=7 Participants	22 Participants n=4 Participants	66 Participants n=21 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Stage at Diagnosis Stage I	9 Participants n=5 Participants	8 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=4 Participants	28 Participants n=21 Participants
Stage at Diagnosis Stage II	3 Participants n=5 Participants	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Stage at Diagnosis Stage III	6 Participants n=5 Participants	4 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=4 Participants	25 Participants n=21 Participants
Stage at Diagnosis Stage IV	17 Participants n=5 Participants	1 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=4 Participants	41 Participants n=21 Participants
Histology Endometrioid	11 Participants n=5 Participants	14 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=4 Participants	42 Participants n=21 Participants
Histology Mixed	5 Participants n=5 Participants	1 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=4 Participants	9 Participants n=21 Participants
Histology Clear Cell	3 Participants n=5 Participants	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Histology Carcinosarcoma	4 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=4 Participants	11 Participants n=21 Participants
Histology Serous	12 Participants n=5 Participants	0 Participants n=5 Participants	3 Participants n=7 Participants	15 Participants n=4 Participants	30 Participants n=21 Participants
Histology Adenocarcinoma not otherwise specified	0 Participants n=5 Participants	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Number of Prior Lines of Therapy 1	10 Participants n=5 Participants	6 Participants n=5 Participants	3 Participants n=7 Participants	27 Participants n=4 Participants	46 Participants n=21 Participants
Number of Prior Lines of Therapy 2	3 Participants n=5 Participants	3 Participants n=5 Participants	6 Participants n=7 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants
Number of Prior Lines of Therapy 3+	22 Participants n=5 Participants	6 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=4 Participants	40 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 39 months

The objective response rate was determined by the frequency of patients who had objective tumor response, determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT or MRI, where objective response represents either a confirmed complete response (CR; disappearance of all target lesions) or a confirmed partial response (PR; at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum diameters); objective response = CR + PR.

Outcome measures

Measure	MSI-H/POLE-Mutated Avelumab Arm n=15 Participants Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm n=16 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Talazoparib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSS Avelumab/Axitinib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.
Objective Response Rate	4 Participants	1 Participants	4 Participants	9 Participants

PRIMARY outcome

Timeframe: 6 months

Progression-free survival at 6 months was determined by the frequency of patients who survived progression-free for at least 6 months after initiating study treatment by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions.

Outcome measures

Measure	MSI-H/POLE-Mutated Avelumab Arm n=15 Participants Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm n=16 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Talazoparib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSS Avelumab/Axitinib Combination Arm n=35 Participants Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.
Progression-Free Survival at 6 Months	6 Participants	1 Participants	8 Participants	14 Participants

SECONDARY outcome

Timeframe: Interval from start of treatment to documented disease progression per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death from any cause, whichever occurs first.

Progression-free survival was determined per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), where disease progression represents at least a 20% increase in the sum of diameters of target lesions, appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. The distribution of progression-free times will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Participants are followed for survival status from registration through up to 3 years after removal from study intervention

Overall survival (OS) is defined as the time from registration to death due to any cause, or censored at date last known alive. The distribution of overall survival times will be estimated using Kaplan-Meier analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Adverse event data was collected for all participants through 30 days after last intervention

As classified by the common terminology criteria for adverse events (CTCAE) version 4.0

Outcome measures

Outcome data not reported

Adverse Events

MSI-H/POLE-Mutated Avelumab Arm

Serious events: 4 serious events

Other events: 15 other events

Deaths: 0 deaths

MSS Avelumab Arm

Serious events: 7 serious events

Other events: 15 other events

Deaths: 3 deaths

MSS Avelumab/Talazoparib Combination Arm

Serious events: 11 serious events

Other events: 35 other events

Deaths: 0 deaths

MSS Avelumab/Axitinib Combination Arm

Serious events: 16 serious events

Other events: 35 other events

Deaths: 1 deaths

Serious adverse events

Measure	MSI-H/POLE-Mutated Avelumab Arm n=15 participants at risk Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm n=16 participants at risk Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Talazoparib Combination Arm n=35 participants at risk Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSS Avelumab/Axitinib Combination Arm n=35 participants at risk Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.
Blood and lymphatic system disorders Anemia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Aortic valve disease	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Chest pain - cardiac	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Heart failure	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Pericarditis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Eye disorders - Other, specify (Hemianopsia)	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Abdominal pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Colitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Colonic obstruction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Constipation	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Diarrhea	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Gastric hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Gastric perforation	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Jejunal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Nausea	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Small intestinal obstruction	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Small intestinal perforation	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Vomiting	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Death NOS	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders General disorders and administration site conditions - Other, specify (Failure to thrive)	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Infusion related reaction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Infections and infestations - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Infections and infestations - Other, specify (Influenza A)	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Infections and infestations - Other, specify (Influenza B)	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Kidney infection	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Sinusitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Urinary tract infection	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Platelet count decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Hyponatremia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify (Failure to thrive)	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Muscle weakness upper limb	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Dizziness	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Headache	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Syncope	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Psychiatric disorders Confusion	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Acute kidney injury	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Cystitis noninfective	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Hematuria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Renal and urinary disorders - Other, specify (Bilateral hydronephrosis)	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Urinary retention	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Hematoma	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Hypertension	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Thromboembolic event	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).

Other adverse events

Measure	MSI-H/POLE-Mutated Avelumab Arm n=15 participants at risk Participants with MSI-H and/or POLE-mutated endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab Arm n=16 participants at risk Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle.	MSS Avelumab/Talazoparib Combination Arm n=35 participants at risk Participants with MSS endometrial cancer received Avelumab at 10 mg/kg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 1mg Talazoparib orally once daily.	MSS Avelumab/Axitinib Combination Arm n=35 participants at risk Participants with MSS endometrial cancer received Avelumab at 800mg intravenously on Day 1 and Day 15 of each 28-day cycle in combination with 5mg Axitinib orally twice daily.
Nervous system disorders Grade 1-2 Dysgeusia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Extrapyramidal disorder	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Headache	33.3% 5/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	34.3% 12/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 1-2 Anemia	40.0% 6/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	31.2% 5/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.7% 9/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 1-2 Blood and lymphatic system disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 1-2 Leukocytosis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 3 Anemia	26.7% 4/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	45.7% 16/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 3 Blood and lymphatic system disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Blood and lymphatic system disorders Grade 4 Anemia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Chest pain - cardiac	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Palpitations	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Pericardial effusion	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Pericarditis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Sinus bradycardia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Sinus tachycardia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 1-2 Ventricular tachycardia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 3 Aortic valve disease	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 3 Heart failure	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 3 Restrictive cardiomyopathy	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Cardiac disorders Grade 3 Sinus bradycardia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Ear and labyrinth disorders Grade 1-2 Ear and labyrinth disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Ear and labyrinth disorders Grade 1-2 Ear pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Ear and labyrinth disorders Grade 1-2 Hearing impaired	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Ear and labyrinth disorders Grade 1-2 Tinnitus	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Ear and labyrinth disorders Grade 1-2 Vertigo	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Endocrine disorders Grade 1-2 Adrenal insufficiency	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Endocrine disorders Grade 1-2 Endocrine disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Endocrine disorders Grade 1-2 Hyperthyroidism	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Endocrine disorders Grade 1-2 Hypothyroidism	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	31.4% 11/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Endocrine disorders Grade 3 Hypothyroidism	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Blurred vision	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Conjunctivitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Dry eye	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Eye disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Eye pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Uveitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Vitreous hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 1-2 Watering eyes	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Eye disorders Grade 3 Eye disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Abdominal distension	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Abdominal pain	33.3% 5/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.0% 4/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	48.6% 17/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Ascites	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Bloating	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Colitis	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Constipation	33.3% 5/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Diarrhea	46.7% 7/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.7% 9/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	57.1% 20/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Dry mouth	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Dyspepsia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Dysphagia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Enterocolitis	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Esophageal pain	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Fecal incontinence	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Flatulence	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Gastroesophageal reflux disease	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Gastrointestinal disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Hemorrhoidal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Hemorrhoids	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Jejunal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Jejunal obstruction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Lip pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Mucositis oral	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Nausea	40.0% 6/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.0% 4/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	45.7% 16/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	51.4% 18/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Oral dysesthesia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Oral hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Oral pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Rectal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Rectal pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Tooth development disorder	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Toothache	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 1-2 Vomiting	33.3% 5/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.0% 4/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Abdominal pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Anal mucositis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Colonic obstruction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Constipation	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Diarrhea	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Gastric hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Jejunal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Mucositis oral	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Small intestinal obstruction	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Small intestinal perforation	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 3 Vomiting	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Gastrointestinal disorders Grade 4 Gastric perforation	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Chills	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Edema face	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Edema limbs	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	28.6% 10/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Edema trunk	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Facial pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Fatigue	46.7% 7/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	43.8% 7/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	42.9% 15/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	60.0% 21/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Fever	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Flu like symptoms	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Gait disturbance	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 General disorders and administration site conditions - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Infusion related reaction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Irritability	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Malaise	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Non-cardiac chest pain	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 1-2 Pain	33.3% 5/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 Edema face	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 Fatigue	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 Flu like symptoms	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 General disorders and administration site conditions - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 Infusion related reaction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
General disorders Grade 3 Pain	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Hepatobiliary disorders Grade 1-2 Hepatobiliary disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Conjunctivitis infective	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Eye infection	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Infections and infestations - Other	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Lung infection	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Mucosal infection	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Papulopustular rash	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Paronychia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Rash pustular	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Sinusitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Skin infection	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Tooth infection	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Upper respiratory infection	26.7% 4/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Urinary tract infection	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Vulval infection	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 1-2 Wound infection	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 3 Infections and infestations - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 3 Kidney infection	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 3 Lung infection	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Infections and infestations Grade 3 Urinary tract infection	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Bruising	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Fall	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Fracture	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Injury to jugular vein	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Injury, poisoning and procedural complications - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Injury, poisoning and procedural complications Grade 1-2 Wrist fracture	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Alanine aminotransferase increased	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	31.4% 11/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Alkaline phosphatase increased	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Aspartate aminotransferase increased	26.7% 4/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	28.6% 10/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Blood bilirubin increased	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Cardiac troponin I increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Cholesterol high	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Creatinine increased	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Hemoglobin increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 INR increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Investigations - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Lymphocyte count decreased	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Neutrophil count decreased	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Platelet count decreased	26.7% 4/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	42.9% 15/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Serum amylase increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Urine output decreased	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 Weight loss	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 1-2 White blood cell decreased	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Alanine aminotransferase increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Alkaline phosphatase increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Aspartate aminotransferase increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Creatinine increased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Lymphocyte count decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Neutrophil count decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 3 Platelet count decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Investigations Grade 4 Platelet count decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Anorexia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	51.4% 18/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Dehydration	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypercalcemia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hyperglycemia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hyperkalemia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypernatremia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypoalbuminemia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypocalcemia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypokalemia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypomagnesemia	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hyponatremia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.0% 4/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Hypophosphatemia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 1-2 Metabolism and nutrition disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Dehydration	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Hypokalemia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Hyponatremia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Hypophosphatemia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Metabolism and nutrition disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Metabolism and nutrition disorders Grade 3 Obesity	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Arthralgia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Arthritis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Back pain	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	31.2% 5/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Bone pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Buttock pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Chest wall pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Flank pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Generalized muscle weakness	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Joint range of motion decreased	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Muscle weakness lower limb	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Musculoskeletal and connective tissue disorder - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Myalgia	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Myositis	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Neck pain	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 1-2 Pain in extremity	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Arthralgia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Back pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Muscle weakness upper limb	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Musculoskeletal and connective tissue disorder - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Myalgia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Myositis	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Neck pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Musculoskeletal and connective tissue disorders Grade 3 Pain in extremity	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Grade 1-2 Neoplasms benign, malignant and unspecified - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Depressed level of consciousness	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Dizziness	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Nervous system disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Paresthesia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Peripheral motor neuropathy	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Peripheral sensory neuropathy	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Presyncope	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Sinus pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Syncope	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 1-2 Tremor	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 3 Encephalopathy	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 3 Peripheral sensory neuropathy	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 3 Syncope	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Nervous system disorders Grade 3 Vasovagal reaction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Psychiatric disorders Grade 1-2 Anxiety	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Psychiatric disorders Grade 1-2 Depression	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Psychiatric disorders Grade 1-2 Insomnia	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Psychiatric disorders Grade 3 Confusion	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Acute kidney injury	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Cystitis noninfective	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Hematuria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Proteinuria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	25.7% 9/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Renal and urinary disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Urinary frequency	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Urinary incontinence	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Urinary retention	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Urinary tract obstruction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 1-2 Urinary tract pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Acute kidney injury	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Chronic kidney disease	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Hematuria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Proteinuria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Renal and urinary disorders - Other	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Renal and urinary disorders Grade 3 Urinary tract obstruction	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Pelvic pain	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	11.4% 4/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Perineal pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Reproductive system and breast disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Vaginal discharge	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Vaginal dryness	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Vaginal hemorrhage	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Reproductive system and breast disorders Grade 1-2 Vaginal pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Allergic rhinitis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Atelectasis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Cough	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	20.0% 7/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Dyspnea	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	18.8% 3/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Epistaxis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Hiccups	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Hoarseness	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Hypoxia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Nasal congestion	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Pleural effusion	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Pneumonitis	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Pneumothorax	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Postnasal drip	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Productive cough	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Pulmonary fibrosis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Pulmonary hypertension	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Respiratory, thoracic and mediastinal disorders	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Sinus disorder	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Sneezing	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Sore throat	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Voice alteration	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 1-2 Wheezing	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 3 Cough	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 3 Dyspnea	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 3 Productive cough	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Respiratory, thoracic and mediastinal disorders Grade 4 Respiratory failure	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Alopecia	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Dry skin	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	17.1% 6/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Hyperhidrosis	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Nail discoloration	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Nail ridging	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Palmar-plantar erythrodysesthesia syndrome	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Pruritus	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	14.3% 5/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Rash acneiform	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Rash maculo-papular	20.0% 3/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Scalp pain	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Skin ulceration	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Skin/subcutaneous tissue disorders - Other	40.0% 6/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	22.9% 8/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 1-2 Urticaria	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 3 Pruritus	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Skin and subcutaneous tissue disorders Grade 3 Rash acneiform	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Surgical and medical procedures Grade 1-2 Surgical and medical procedures - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Flushing	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Hematoma	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Hypertension	13.3% 2/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	28.6% 10/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Hypotension	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	8.6% 3/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Thromboembolic event	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 1-2 Vascular disorders - Other	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 3 Hypertension	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	6.2% 1/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	37.1% 13/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 3 Thromboembolic event	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	12.5% 2/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	5.7% 2/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 4 Hematoma	6.7% 1/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).
Vascular disorders Grade 4 Hypertension	0.00% 0/15 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/16 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	0.00% 0/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).	2.9% 1/35 • Adverse event data was collected for all participants through 30 days after last intervention (up to 85 months).

Additional Information

Dr. Panagiotis Konstantinopoulos

Dana-Farber Cancer Institute

Phone: 617-632-5269

Email: Panagiotis_Konstantinopoulos@dfci.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place