Trial Outcomes & Findings for Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia (NCT NCT02397720)

Last Updated: 2025-06-08

Results Overview

The maximum tolerated dose is defined as the highest dose level of 5-azacitidine with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

150 participants

Primary outcome timeframe

Up to 28 days

Results posted on

2025-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 1 B (Azacitidine, Nivolumab) Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Overall Study STARTED	6	85	6	47	6
Overall Study COMPLETED	6	85	6	47	6
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 1 B (Azacitidine, Nivolumab) n=85 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=6 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 3 B (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Total n=150 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	25 Participants n=7 Participants	3 Participants n=5 Participants	21 Participants n=4 Participants	2 Participants n=21 Participants	0 Participants n=10 Participants	54 Participants n=115 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	60 Participants n=7 Participants	3 Participants n=5 Participants	26 Participants n=4 Participants	4 Participants n=21 Participants	0 Participants n=10 Participants	96 Participants n=115 Participants
Age, Continuous	60 years n=5 Participants	71 years n=7 Participants	66 years n=5 Participants	66 years n=4 Participants	67 years n=21 Participants	—	69 years n=115 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	25 Participants n=7 Participants	3 Participants n=5 Participants	18 Participants n=4 Participants	3 Participants n=21 Participants	—	50 Participants n=115 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	60 Participants n=7 Participants	3 Participants n=5 Participants	29 Participants n=4 Participants	3 Participants n=21 Participants	—	100 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	2 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	5 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	8 Participants n=115 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	70 Participants n=7 Participants	5 Participants n=5 Participants	43 Participants n=4 Participants	5 Participants n=21 Participants	—	127 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	9 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	—	13 Participants n=115 Participants
Region of Enrollment United States	6 participants n=5 Participants	85 participants n=7 Participants	6 participants n=5 Participants	47 participants n=4 Participants	6 participants n=21 Participants	—	150 participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All participants were treated at dose level 0, the starting dose.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=6 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Maximum Tolerated Dose of 5-azacytidine in the Combination of Nivolumab With Dihydro-5-azacytidine	75 Mg/m^2	75 Mg/m^2	75 Mg/m^2	—	—

PRIMARY outcome

Timeframe: Up to 7 years, 6 months

Population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Responders are patients who obtain a Complete Remission (CR), Complete Remission with Incomplete blood count recovery CRi, Complete Remission with Incomplete Platelet Recovery (CRp) or Partial Remission (PR), with or without cytogenetic response, hematologic improvements (HI), and morphologic leukemia-free state. CR is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L, Platelet count \>/= 100 x 10 \^9/L. Bone marrow \</= 5% blasts, No auer rods, No extramedullary disease. CRp is patients who have achieved a CR except for incomplete platelet recovery (\<100 x 10\^9/L). CRi is counts of 0 circulating blasts, Neutrophil count of \>/= 1.0 x 10\^9/L OR Platelet count \>/= 100 x 10 \^9/L. PR is All CR criteria if abnormal before treatment except \>/= 50% reduction in bone marrow blast but still \>5%. morphologic leukemia-free state is Bone marrow: \</=5% myeloblasts. HI is Hematologic response must be described by the number of positively affected cell lines.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=85 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Participants With a Response	2 Participants	34 Participants	2 Participants	13 Participants	4 Participants

PRIMARY outcome

Timeframe: Up to 28 days

Population: All participants were treated at dose level 0, the starting dose.

The maximum tolerated dose is defined as the highest dose level of nivolumab with \< 2 out of 6 patients experiencing a dose limiting toxicity during the first 28 days of treatment. The starting dose level for Azacitidine is 75 mg/m\^2 and the starting dose level for Nivolumab is 3.0 mg/kg.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=6 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Maximum Tolerated Dose of Nivolumab in the Combination of Nivolumab With Dihydro-5-azacytidine	3 mg/kg	3 mg/kg	3 mg/kg	—	—

SECONDARY outcome

Timeframe: Up to 7 years, 6 months

Population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Time from date of treatment start until the date of first objective documentation of disease-relapse.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=2 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=34 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=2 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=13 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=2 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Disease-free Survival	3.0 Months Interval 2.9 to 3.1	7.1 Months Interval 0.4 to 90.0	4.1 Months Interval 0.1 to 8.2	2.0 Months Interval 0.0 to 5.7	2.9 Months Interval 0.9 to 4.9

SECONDARY outcome

Timeframe: Up to 7 years, 6 months

Population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Time from date of treatment start until date of death due to any cause or last Follow-up.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=85 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Overall Survival	5.9 Months Interval 3.5 to 16.2	6.6 Months Interval 0.3 to 90.0	8.3 Months Interval 3.1 to 32.4	6.7 Months Interval 0.4 to 71.5	1.4 Months Interval 1.0 to 8.8

SECONDARY outcome

Timeframe: Up to 7 years, 6 months

Population: There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Time from date of treatment start until the date of progression or death from leukemia.

Outcome measures

Outcome measures
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 Participants Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=85 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 Participants Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 Participants Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Progression-free Survival	3.5 Months Interval 2.3 to 16.2	3.5 Months Interval 0.3 to 90.0	3.2 Months Interval 1.6 to 11.9	3.6 Months Interval 0.2 to 15.8	1.3 Months Interval 1.0 to 8.8

Adverse Events

Arm 1 A Lead-In (Azacitidine, Nivolumab)

Serious events: 6 serious events

Other events: 6 other events

Deaths: 1 deaths

Arm 1 B (Azacitidine, Nivolumab)

Serious events: 57 serious events

Other events: 62 other events

Deaths: 16 deaths

Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab)

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Arm 2 B (Azacitidine, Nivolumab, Ipilimumab)

Serious events: 33 serious events

Other events: 25 other events

Deaths: 5 deaths

Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax)

Serious events: 5 serious events

Other events: 4 other events

Deaths: 1 deaths

Arm 3 B (Azacitidine, Nivolumab, Venetoclax)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 participants at risk Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 1 B (Azacitidine, Nivolumab) n=85 participants at risk Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=6 participants at risk Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 participants at risk Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 participants at risk Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 3 B (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Infections and infestations Catheter related infection	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Immune system disorders Cytokine release syndrome	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	29.4% 25/85 • Number of events 36 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	31.9% 15/47 • Number of events 22 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders General disorders and administration site conditions	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Hypoxia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Lung infection	33.3% 2/6 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	37.6% 32/85 • Number of events 45 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	31.9% 15/47 • Number of events 25 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Lumbar Spine Stenosis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Pneumonitis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Skin infection	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Abdominal Pain	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Renal and urinary disorders Acute Kidney Injury	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Anorectal infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Immune system disorders Autoimmune disorder	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Back pain	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Bladder infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Chest pain cardiac	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Colitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Duodenal ulcer	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Edema cerebral	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Eye infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Fall	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Fatigue	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Fever	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Fracture	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Gastrointestinal disorders	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Generalized muscle weakness	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Heart failure	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Renal and urinary disorders Hematuria	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Hemorrhoidal hemorrhage	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Hepatobiliary disorders Hepatobiliary disorders	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Hypercalcemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Hypocalcemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Vascular disorders Hypotension	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Hypothyroidism	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Ileus	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Infection	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	11.8% 10/85 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	12.8% 6/47 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Intracranial hemorrhage	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Investigations	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Laryngitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Lower gastrointestinal hemorrhage	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Multi organ failure	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Nausea	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Pain	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Periorbital infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Platelet count decreased	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Proctitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Altered Mental Status	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Rash maculo papular	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Scrotal infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Sepsis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	17.0% 8/47 • Number of events 11 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Sinus tachycardia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Sinusitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Soft tissue infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Spinal fracture	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Stroke	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Surgical and medical procedures Surgical and medical procedures Biliary Drain Removal	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Syncope	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Tumor lysis syndrome	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Upper respiratory infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Urinary tract infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Vomiting	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Wound infection	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Other adverse events

Other adverse events
Measure	Arm 1 A Lead-In (Azacitidine, Nivolumab) n=6 participants at risk Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 1 B (Azacitidine, Nivolumab) n=85 participants at risk Patients receive azacitidine IV over 1 hour or SC on days 1-7 or days 1-4 and 7-9. Patients also receive nivolumab IV over 60 minutes on days 1 and 14 (courses 1-4) or on day 1 (course 5 and all subsequent courses). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Nivolumab: Given IV	Arm 2 A Lead-In (Azacitidine, Nivolumab, Ipilimumab) n=6 participants at risk Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 2 B (Azacitidine, Nivolumab, Ipilimumab) n=47 participants at risk Patients receive azacitidine and nivolumab as Arm I. Patients also receive ipilimumab IV over 90 minutes on day 1 and then every 6 or 12 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Ipilimumab Nivolumab: Given IV	Arm 3 A Lead-In (Azacitidine, Nivolumab, Venetoclax) n=6 participants at risk Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV	Arm 3 B (Azacitidine, Nivolumab, Venetoclax) Patients will receive therapy with nivolumab IV infusion on Day 8 and Day 22 (+/-3 days) of each 5-azacyidine cycle for first 4 cycles or until CR (whichever occurs earlier) followed by a maintenance regimen (one dose of nivolumab on Day 8 of each cycle of 5-azacytdine). Venetoclax will be administered orally daily on Days 1-21 of the first cycle; and Days 1-14 or Days 1-21 for subsequent cycles. Azacitidine: Given SC or IV Venetoclax: Given Orally Nivolumab: Given IV
Gastrointestinal disorders Abdominal Distension	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Acidosis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Adrenal insufficiency	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Alanine aminotransferase increased	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	10.6% 5/47 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Alkaline phosphatase increased	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Anemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Anorexia	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Anxiety	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Atrial fibrillation	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Benign Prostatic Hyperplasia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Myelosuppression	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Blood bilirubin increased	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Chills	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Renal and urinary disorders Chronic kidney disease	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Cognitive disturbance	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Confusion	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Constipation	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	20.0% 17/85 • Number of events 22 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Creatinine increased	16.7% 1/6 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Immune system disorders Cytokine release syndrome	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Dehydration	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Depression	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Diarrhea	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	21.2% 18/85 • Number of events 28 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Dizziness	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Dry skin	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Ear and labyrinth disorders Ear and labyrinth disorders	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Edema	50.0% 3/6 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	7.1% 6/85 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Endocrine disorders	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Epistaxis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Erythema multiforme	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Eye disorders Eye Disorders	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Fall	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Fatigue	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	15.3% 13/85 • Number of events 21 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Fever	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Fracture	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Gastrointestinal disorders	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders General disorders and administration site conditions	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Vascular disorders Hematoma	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Renal and urinary disorders Hematuria	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Hemorrhage	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Hemorrhoids	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Hoarseness	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hyperglycemia	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Hyperhidrosis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Vascular disorders Hypertension	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypoalbuminemia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 8 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	14.9% 7/47 • Number of events 13 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hyponatremia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.7% 4/85 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Vascular disorders Hypotension	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	7.1% 6/85 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Endocrine disorders Hypothyroidism	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Ileus	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Infection	33.3% 2/6 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	11.8% 10/85 • Number of events 12 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	12.8% 6/47 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Infusion related reaction	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Insomnia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Investigations	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Psychiatric disorders Libido decreased	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Lung infection	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	9.4% 8/85 • Number of events 9 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	10.6% 5/47 • Number of events 6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Mucositis oral	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Nasal congestion	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Nausea	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	11.8% 10/85 • Number of events 17 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Nervous system disorders	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	14.9% 7/47 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
General disorders Pain	66.7% 4/6 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	11.8% 10/85 • Number of events 32 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	12.8% 6/47 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 8 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Palpitations	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Pancreatitis	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Platelet count decreased	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Pneumonitis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	7.1% 6/85 • Number of events 8 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Postnasal drip	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Blood and lymphatic system disorders Purpura	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Rash	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	7.1% 6/85 • Number of events 9 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Renal and urinary disorders Renal and urinary disorders	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Reproductive system and breast disorders Reproductive system and breast disorders	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.4% 2/85 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.5% 4/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Restrictive cardiomyopathy	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Infections and infestations Sepsis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	5.9% 5/85 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Sinus bradycardia	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	3.5% 3/85 • Number of events 4 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.2% 7/85 • Number of events 8 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	6.4% 3/47 • Number of events 5 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	83.3% 5/6 • Number of events 7 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	7.1% 6/85 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	10.6% 5/47 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	33.3% 2/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Somnolence	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Injury, poisoning and procedural complications Spinal fracture	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Syncope	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Vascular disorders Thromboembolic event	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	4.3% 2/47 • Number of events 2 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Skin and subcutaneous tissue disorders Toxic epidermal necrolysis	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Nervous system disorders Tremor	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/85 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/47 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Gastrointestinal disorders Vomiting	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	8.2% 7/85 • Number of events 10 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	50.0% 3/6 • Number of events 3 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.
Investigations Weight loss	16.7% 1/6 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	1.2% 1/85 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	2.1% 1/47 • Number of events 1 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	0.00% 0/6 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.	— 0/0 • Up to 7 years, 6 months There were Zero participants enrolled on Arm 3 B due to no responses in the lead in phase.

Additional Information

Naval Daver MD./Professor

The University of Texas MD Anderson Cancer Center

Phone: 713-794-4392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place