Trial Outcomes & Findings for Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers (NCT NCT03388632)

Last Updated: 2025-12-18

Results Overview

Here is the maximum tolerated dose (MTD) (i.e., highest dose) of rhIL-15 administered in combination with fixed doses of nivolumab and ipilimumab at which dose-limiting toxicities occurred in ≤1 of 6 participants during cycle 1, dose escalation in participants receiving the triplet combination. A DLT is defined as an adverse event that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

31 participants

Primary outcome timeframe

Cycle 1 (42 days)

Results posted on

2025-12-18

Participant Flow

Participant milestones

Participant milestones
Measure	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Lead-In Doublet A STARTED	2	1	0	0	0	0	0	0	0
Lead-In Doublet A COMPLETED	2	1	0	0	0	0	0	0	0
Lead-In Doublet A NOT COMPLETED	0	0	0	0	0	0	0	0	0
Lead-In Doublet B STARTED	0	0	2	0	0	0	0	0	0
Lead-In Doublet B COMPLETED	0	0	2	0	0	0	0	0	0
Lead-In Doublet B NOT COMPLETED	0	0	0	0	0	0	0	0	0
Triplet C STARTED	0	0	0	2	18	2	1	2	1
Triplet C COMPLETED	0	0	0	2	16	1	1	1	0
Triplet C NOT COMPLETED	0	0	0	0	2	1	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Triplet C Clinical progression	1	0	0	0
Triplet C 42-day lapse in tx	1	0	0	0
Triplet C Adverse Event	0	0	0	1
Triplet C Switched to alternative treatment	0	0	1	0
Triplet C Participant choice	0	1	0	0

Baseline Characteristics

Recombinant Interleukin-15 in Combination With Checkpoint Inhibitors Nivolumab and Ipilimumab in People With Refractory Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 Participants Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=18 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	0 Participants n=39438 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants	2 Participants n=9 Participants	15 Participants n=3 Participants	2 Participants n=195 Participants	1 Participants n=585 Participants	2 Participants n=19829 Participants	1 Participants n=77547 Participants	27 Participants n=39438 Participants
Age, Categorical >=65 years	0 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants	0 Participants n=9 Participants	3 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	4 Participants n=39438 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 12.02 • n=47 Participants	49 years STANDARD_DEVIATION 0 • n=41 Participants	51 years STANDARD_DEVIATION 26.87 • n=88 Participants	53 years STANDARD_DEVIATION 1.41 • n=9 Participants	56.14 years STANDARD_DEVIATION 12.04 • n=3 Participants	52 years STANDARD_DEVIATION 11.31 • n=195 Participants	55 years STANDARD_DEVIATION 0 • n=585 Participants	49 years STANDARD_DEVIATION 4.24 • n=19829 Participants	60 years STANDARD_DEVIATION 0 • n=77547 Participants	54.55 years STANDARD_DEVIATION 11.64 • n=39438 Participants
Sex: Female, Male Female	0 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants	1 Participants n=9 Participants	12 Participants n=3 Participants	0 Participants n=195 Participants	1 Participants n=585 Participants	2 Participants n=19829 Participants	1 Participants n=77547 Participants	18 Participants n=39438 Participants
Sex: Female, Male Male	2 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants	1 Participants n=9 Participants	6 Participants n=3 Participants	2 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	13 Participants n=39438 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	3 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	3 Participants n=39438 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=47 Participants	1 Participants n=41 Participants	2 Participants n=88 Participants	2 Participants n=9 Participants	15 Participants n=3 Participants	2 Participants n=195 Participants	1 Participants n=585 Participants	2 Participants n=19829 Participants	1 Participants n=77547 Participants	28 Participants n=39438 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	0 Participants n=39438 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	0 Participants n=39438 Participants
Race (NIH/OMB) Asian	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	1 Participants n=3 Participants	1 Participants n=195 Participants	1 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	3 Participants n=39438 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	0 Participants n=39438 Participants
Race (NIH/OMB) Black or African American	1 Participants n=47 Participants	0 Participants n=41 Participants	1 Participants n=88 Participants	1 Participants n=9 Participants	3 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	6 Participants n=39438 Participants
Race (NIH/OMB) White	1 Participants n=47 Participants	1 Participants n=41 Participants	1 Participants n=88 Participants	1 Participants n=9 Participants	13 Participants n=3 Participants	1 Participants n=195 Participants	0 Participants n=585 Participants	2 Participants n=19829 Participants	1 Participants n=77547 Participants	21 Participants n=39438 Participants
Race (NIH/OMB) More than one race	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	0 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	0 Participants n=39438 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=47 Participants	0 Participants n=41 Participants	0 Participants n=88 Participants	0 Participants n=9 Participants	1 Participants n=3 Participants	0 Participants n=195 Participants	0 Participants n=585 Participants	0 Participants n=19829 Participants	0 Participants n=77547 Participants	1 Participants n=39438 Participants
Region of Enrollment United States	2 participants n=47 Participants	1 participants n=41 Participants	2 participants n=88 Participants	2 participants n=9 Participants	18 participants n=3 Participants	2 participants n=195 Participants	1 participants n=585 Participants	2 participants n=19829 Participants	1 participants n=77547 Participants	31 participants n=39438 Participants

PRIMARY outcome

Timeframe: Cycle 1 (42 days)

Population: This analysis includes participants (pts) from multiple groups, as different groups received different doses of rhIL-15. Includes pts from group 4 (n=2), group 5 (n=9), group 6 (n=2), group 7 (n=1), group 8 (n=2), and group 9(n=1). Of the 18 pts in group 5, 9 pts were enrolled in the dose escalation phase to determine MTD \& an additional 9 pts were enrolled in an expansion cohort at that dose after the MTD was determined. Pts in this expansion cohort were not included in the MTD determination.

Outcome measures

Outcome measures
Measure	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=17 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Maximum Tolerated Dose (MTD) at Which Dose-Limiting Toxicities (DLT) Occurred With rhIL-15 Administered in Combination With Fixed Doses of Nivolumab and Ipilimumab	—	—	1.0 mcg/kg/day	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Cycle 1 (42 days)

Population: As pre-specified in the protocol, DLT's were assessed in the lead-in doublet arms and the triplet escalation phase groups only.

A DLT is defined as an adverse event (AE) that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.

Outcome measures

Outcome measures
Measure	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 Participants Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=18 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Possibly related to rh IL-15	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Probably related to rh IL-15	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Definitely related to rh IL-15	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Possibly related to Nivolumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Probably related to Nivolumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Definitely related to Nivolumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Possibly related to Ipilimumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Probably related to Ipilimumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities
Number of Dose-limiting Toxicities (DLT) Possibly, Probably, or Definitely Related to Study Drugs Definitely related to Ipilimumab	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities	0 toxicities

PRIMARY outcome

Timeframe: Cycle 1 (42 days)

Population: Of the 18 participants in group 5, 9 participants were enrolled in the dose escalation phase to determine maximum tolerated dose (MTD), and an additional 9 participants were enrolled in an expansion cohort at that dose after the MTD was determined. Participants in this expansion cohort were not included in this DLT evaluation per protocol.

Here is the number of participants experiencing dose-limiting toxicities (DLT). A DLT is defined as an adverse event that is felt to be related (possibly, probably, or definitely) to administration of study drugs, and meets prespecified criteria, including any condition requiring long-term treatment with corticosteroids or permanent discontinuation of one of the agents.

Outcome measures

Outcome measures
Measure	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 Participants Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=9 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Number of Participants Experiencing Dose-Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.

Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 Participants Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 Participants Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=18 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 Participants Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0)	2 Participants	1 Participants	2 Participants	1 Participants	2 Participants	2 Participants	18 Participants	2 Participants	1 Participants

Adverse Events

Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 13 serious events

Other events: 18 other events

Deaths: 1 deaths

Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 participants at risk Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 participants at risk Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 participants at risk Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=18 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Endocrine disorders Adrenal insufficiency	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Alanine aminotransferase increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Blood and lymphatic system disorders Anemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Atrial fibrillation	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Bronchopulmonary hemorrhage	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Colitis	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Complicated kidneystone removal procedure	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Disease progression	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Dizziness	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Fatigue	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Fever	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Flu-like symptoms	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Headache	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Hematuria	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Hypertension	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Hyperthyroidism	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Hypophysitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Hypotension	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Injury, poisoning and procedural complications Infusion-related reaction	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Intracranial hemorrhage	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Myocarditis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Neutrophil count decreased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Pyelonephritis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Renal calculi	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Spinal cord compression	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Superior vena cava syndrome	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Syncope	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Thromboembolic event	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Transient ischemic attack	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Urinary tract infection	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations White blood cell decreased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.

Other adverse events

Other adverse events
Measure	Arm A Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=2 participants at risk Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm A/Arm A1 Doublet A - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Nivolumab 240mg n=1 participants at risk Doublet A, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Nivolumab intravenous (IV) d8, 22, \& 36. Cycles 5+, Nivolumab alone (IV d1, 15 \& 29) after Doublet A. DOUBLET A: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36; Cycle 5+ Nivolumab 240 mg IV over 60 min d1, 15 \& 29.	Arm B Doublet B - Recombinant Human Interleukin (rH IL-15) 0.5mcg/kg & Ipilimumab 1mg/kg n=2 participants at risk Doublet B, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29 and Ipilimumab intravenous (IV) d8. DOUBLET B: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& 22-29 plus Ipilimumab 1 mg/kg IV over 90-minute (min) d8; Cycle 5+ Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 1-Recombinant Human Interleukin(rHIL-15) 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 2-Recombinant Human Interleukin(rHIL-15) 1mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=18 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3-Recombinant Human Interleukin(rHIL-15) 2mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C Triplet 3/Triplet 2/Recombinant Human Interleukin 2mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=1 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. TRIPLET 3: Cycle 1-4, IL-15: 2 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 1 - Recombinant Human Interleukin 0.5mcg/kg/Nivolumab 240mg/Ipilimumab 1mg/kg n=2 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 1: Cycle 1-4, IL-15: 0.5 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.	Arm C/Arm C1 Triplet 2-Recombinant Human Interleukin 1mcg/kg & Nivolumab 240mg/Ipilimumab 1mg/kg n=1 participants at risk Triplet, cycles 1-4: Recombinant Human Interleukin (rH IL-15) subcutaneous (SC) day(d)1-8 \& 22-29, Nivolumab intravenous (IV) d8, 22, \& 36 and Ipilimumab IV d8. Triplet, cycles 5+ Nivolumab IV d1, 15, \& 29 and Ipilimumab IV d1. TRIPLET 2: Cycle 1-4, IL-15: 1 mcg/kg subcutaneously on d1-8 \& d22-29 plus Nivolumab 240 mg IV over 60-minute (min) d8, 22, \& 36 and Ipilimumab 1 mg/kg IV over 90 min d8; Cycle 5+ Nivolumab 240 mg IV over 60 min on d1, 15 \& 29 plus Ipilimumab 1 mg/kg IV over 90 min d1.
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Adrenal insufficiency	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Alanine aminotransferase increased	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	38.9% 7/18 • Number of events 15 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Alkaline phosphatase increased	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	38.9% 7/18 • Number of events 12 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Immune system disorders Allergic reaction	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Blood and lymphatic system disorders Anemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	83.3% 15/18 • Number of events 57 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 33 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Anorexia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 9/18 • Number of events 14 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Psychiatric disorders Anxiety	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Ascites	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Aspartate aminotransferase increased	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	55.6% 10/18 • Number of events 23 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 11 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	27.8% 5/18 • Number of events 9 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Bloating	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Blood bilirubin increased	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 11 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 12 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Cardiac troponin I increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Chills	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	77.8% 14/18 • Number of events 23 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Cholesterol high	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 15 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Colitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Conjunctivitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Constipation	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Cough	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations CPK increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Creatinine increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Psychiatric disorders Depression	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Diarrhea	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	33.3% 6/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Dizziness	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Dry mouth	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Dysgeusia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Dysphasia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Ear and labyrinth disorders Ear pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Edema limbs	100.0% 2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Endocrine disorders - Other, specify: Hypophysitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Endocrine disorders - Other, specify: TSH increase	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 9 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Eye disorders Eye disorders - Other, specify: Kaleidescopic vision	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Eye disorders Eye disorders - Other, specify: black eye	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Eye disorders Eye disorders - Other, specify: stye	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Injury, poisoning and procedural complications Fall	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Fatigue	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	61.1% 11/18 • Number of events 18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 13 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Fever	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	66.7% 12/18 • Number of events 27 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Flank pain	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Flatulence	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Flu like symptoms	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Injury, poisoning and procedural complications Fracture	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations GGT increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Gastroesophageal reflux disease	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify: belching	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Glucose intolerance	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Headache	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Ear and labyrinth disorders Hearing impaired	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Hematuria	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 10 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Hemoglobinuria	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Hoarseness	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Hot flashes	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hyperglycemia	100.0% 2/2 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	72.2% 13/18 • Number of events 21 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 12 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypermagnesemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	27.8% 5/18 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hyperphosphatemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Hypertension	100.0% 2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 10 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	61.1% 11/18 • Number of events 23 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 29 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Hyperthyroidism	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	38.9% 7/18 • Number of events 12 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypoglycemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypokalemia	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 9 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	66.7% 12/18 • Number of events 22 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 13 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Hypotension	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Endocrine disorders Hypothyroidism	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations INR increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Infections and infestations - Other, specify: COVID-19	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Infections and infestations - Other, specify: thrush	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Injection site reaction	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	72.2% 13/18 • Number of events 20 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Psychiatric disorders Insomnia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Lactate dehydrogenase increased	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	38.9% 7/18 • Number of events 12 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Lipase increased	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	27.8% 5/18 • Number of events 19 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Lymphocyte count decreased	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	44.4% 8/18 • Number of events 18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Lymphocyte count increased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Malaise	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Memory impairment	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Mucositis oral	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Muscle cramp	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: Upper back spasms	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: cramp in legs	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorder - Other, specify: tenosynovitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Nausea	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	27.8% 5/18 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Neutrophil count decreased	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	27.8% 5/18 • Number of events 13 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Non-cardiac chest pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
General disorders Pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 9 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Palpitations	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Papulopustular rash	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Paresthesia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Photosensitivity	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Platelet count decreased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	55.6% 10/18 • Number of events 25 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Pleural effusion	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Proteinuria	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	55.6% 10/18 • Number of events 19 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 10 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Pruritus	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 6 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Rectal hemorrhage	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Dysuria	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify: Glucosuria	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Renal and urinary disorders - Other, specify: protein/creatine ratio increase	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	33.3% 6/18 • Number of events 10 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Renal calculi	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify: Rhinorrhea	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Serum amylase increased	50.0% 1/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	16.7% 3/18 • Number of events 8 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Sinus bradycardia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Sinus tachycardia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	44.4% 8/18 • Number of events 13 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Sinusitis	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Rash Dermatitis NOS	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Dermatitis NOS	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Stomach pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Lipoma	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: Rash	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: abrasion scrotum	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: chest rash	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: eczema	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify: erythematous macule	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Sore throat	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Surgical and medical procedures Surgical and medical procedures - Other, specify: compli kidney stone removal prod	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Vascular disorders Thromboembolic event	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Ear and labyrinth disorders Tinnitus	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Tooth infection	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Toothache	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Renal and urinary disorders Urinary frequency	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Infections and infestations Urinary tract infection	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	11.1% 2/18 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	5.6% 1/18 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Cardiac disorders Ventricular arrhythmia	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Gastrointestinal disorders Vomiting	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	33.3% 6/18 • Number of events 11 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Weight gain	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations Weight loss	50.0% 1/2 • Number of events 4 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	22.2% 4/18 • Number of events 7 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/18 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.
Investigations White blood cell decreased	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 1/1 • Number of events 2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 5 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	100.0% 2/2 • Number of events 3 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	38.9% 7/18 • Number of events 23 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/2 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	50.0% 1/2 • Number of events 21 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.	0.00% 0/1 • All-Cause Mortality was monitored/assessed up to approximately 23 months. Adverse Events were monitored/assessed from the first study intervention through 30 days after the study agent (s) was/were administered up to approximately 23 months.

Additional Information

Dr. Jiran Ahmed

National Cancer Institute

Phone: 240-781-4042

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place