Trial Outcomes & Findings for Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma (NCT NCT03703375)

Last Updated: 2024-07-08

Results Overview

PFS is defined as the time from randomization into the study to the first observation of documented disease progression (local assessment using Lugano Response Criteria 2014) or death due to any cause, whichever occurs first. If a participant has not progressed or died, PFS will be censored at the time of last visit with adequate assessment. C2 censoring rules were used per US FDA guidance 2015. Progression will be determined as per Response criteria for lymphoma: Lugano classification.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

93 participants

Primary outcome timeframe

From randomization up to documented disease progression or death, whichever occurs first (up to approximately 15 months)

Results posted on

2024-07-08

Participant Flow

93 participants were enrolled in the study. 86 participants received study treatment in the main study and 7 participants received doses in the safety run-in to monitor for dose limiting toxicities (DLTs). The safety run-in participants are pre-specified to be excluded from the analysis from primary and secondary outcome measures.

Participant milestones

Participant milestones
Measure	Oral Azacitidine Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy - Romidepsin Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Bendamustine Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle	Investigators Choice Therapy - Gemcitabine Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Pre-Randomization (Safety Run-In) STARTED	7	0	0	0
Pre-Randomization (Safety Run-In) COMPLETED	7	0	0	0
Pre-Randomization (Safety Run-In) NOT COMPLETED	0	0	0	0
Randomization Period STARTED	49	4	16	24
Randomization Period Safety Run-In	7	0	0	0
Randomization Period COMPLETED	42	4	16	23
Randomization Period NOT COMPLETED	7	0	0	1
Treatment Period STARTED	42	4	16	23
Treatment Period COMPLETED	0	0	4	5
Treatment Period NOT COMPLETED	42	4	12	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral Azacitidine Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy - Romidepsin Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Bendamustine Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle	Investigators Choice Therapy - Gemcitabine Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Randomization Period Withdrawal by Subject	0	0	0	1
Randomization Period Completed safety run-in treatment	7	0	0	0
Treatment Period Other Reasons	0	1	0	3
Treatment Period Consent Withdrawal	0	0	0	1
Treatment Period Death	1	0	1	2
Treatment Period Toxicity of Study Treatment	2	0	4	1
Treatment Period Progression	32	1	7	11
Treatment Period Completed treatment	7	2	0	0

Baseline Characteristics

Race data was not collected

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral Azacitidine n=49 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy - Romidepsin n=4 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Bendamustine n=16 Participants Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle	Investigators Choice Therapy - Gemcitabine n=24 Participants Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.	Total n=93 Participants Total of all reporting groups
Age, Continuous	69.3 Years STANDARD_DEVIATION 9.28 • n=49 Participants	67.0 Years STANDARD_DEVIATION 7.16 • n=4 Participants	60.8 Years STANDARD_DEVIATION 9.90 • n=16 Participants	69.4 Years STANDARD_DEVIATION 10.80 • n=24 Participants	67.8 Years STANDARD_DEVIATION 10.11 • n=93 Participants
Sex: Female, Male Female	22 Participants n=49 Participants	1 Participants n=4 Participants	6 Participants n=16 Participants	9 Participants n=24 Participants	38 Participants n=93 Participants
Sex: Female, Male Male	27 Participants n=49 Participants	3 Participants n=4 Participants	10 Participants n=16 Participants	15 Participants n=24 Participants	55 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) Asian	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) Black or African American	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) White	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) More than one race	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Race (NIH/OMB) Unknown or Not Reported	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected	0 Participants Race data was not collected
Region of Enrollment Asia	15 Participants n=49 Participants	4 Participants n=4 Participants	0 Participants n=16 Participants	3 Participants n=24 Participants	22 Participants n=93 Participants
Region of Enrollment Europe	34 Participants n=49 Participants	0 Participants n=4 Participants	16 Participants n=16 Participants	21 Participants n=24 Participants	71 Participants n=93 Participants

PRIMARY outcome

Timeframe: From randomization up to documented disease progression or death, whichever occurs first (up to approximately 15 months)

Population: Intent-to-Treat (ITT) population: all participants having signed their informed consent and who are randomized into the trial, regardless of they received study treatment or not. This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=42 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=44 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Progression Free Survival (PFS) Based on Local Assessment	5.6 Months Interval 2.66 to 7.26	2.8 Months Interval 1.87 to 4.83

SECONDARY outcome

Timeframe: From randomization up to the date of death or date last known alive (up to approximately 27 months)

Overall survival is defined as the time from the date of randomization to the date of death from any cause. OS was censored at the last date that the participant was known to be alive.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=42 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=44 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Overall Survival (OS)	18.4 Months Interval 12.88 to 31.47	10.3 Months Interval 4.24 to 13.5

SECONDARY outcome

Timeframe: From randomization up to documented disease progression or death, whichever occurs first (up to approximately 37 months)

PFS based on Independant Review Committee (IRC) is defined as the time from randomization into the study to the first observation of documented disease progression (reviewed assessment by IRC using Lugano Response Criteria 2014) or death due to any cause. If a patient has not progressed or died, PFS will be censored at the time of last visit with adequate assessment per FDA's guidance 2015 Table C2. Progression will be determined as per Response criteria for lymphoma: Lugano classification.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=42 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=44 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Progression Free Survival (PFS) Based on IRC Assessment	4.2 Months Interval 2.66 to 5.88	3.2 Months Interval 2.1 to 4.83

SECONDARY outcome

Timeframe: Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months)

Population: CR and PR responders in Intent-to-Treat population. This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered.

Overall response rates are the percentage of complete response (CR) and partial response (PR) per local assessment. Assessment of response will be based on Lugano Response Criteria 2014 for the radiologic response (CT based), the metabolic response (PET-CT based) and the best response between radiologic and metabolic response. Measurements occurred after Cycle 3, after Cycle 6, and at permanent treatment discontinuation. PR is defined as Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size and ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. CR is defined as target nodes/nodal masses regressed to ≤ 1.5 cm in LDi, no extralymphatic sites of disease, and Score 1, 2, or 3 with or without a residual mass on the 5 Point Scale. The Lugano 5-point scale is 1, no uptake above background; 2, uptake mediastinum; 3, uptake mediastinum but liver; 4, uptake moderately liver; 5, uptake markedly higher than liver and/or new lesions.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=14 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=19 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Overall Response Rates (ORR) Cycle 3	33.3 Percentage of participants Interval 19.6 to 49.5	43.2 Percentage of participants Interval 28.3 to 59.0
Overall Response Rates (ORR) Cycle 6	31.0 Percentage of participants Interval 17.6 to 47.1	22.7 Percentage of participants Interval 11.5 to 37.8

SECONDARY outcome

Timeframe: Response rate will be measured after Cycle 3, after Cycle 6 (up to approximately 5.5 months)

Population: CR and PR responders in Intent-to-Treat population This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered.

Complete response rate is the percentage of CR (complete metabolic response or CT-based CR) per local assessment before receiving any subsequent anti-lymphoma therapy. Assessment will be based on Lugano Response Criteria 2014 for the radiologic response (CT based), the metabolic response (PET-CT based) and best response between radiologic and metabolic response. Measurements occurred after Cycle 3, Cycle 6, and treatment discontinuation. PR is defined as Score 4 or 5 with reduced uptake compared with baseline and residual mass(es) of any size and ≥ 50% decrease in SPD of up to 6 target measurable nodes and extranodal sites. CR is defined as target nodes/nodal masses regressed to ≤ 1.5 cm in LDi, no extralymphatic sites of disease, and Score 1, 2, or 3 with or without a residual mass. The Lugano 5-point scale is 1, no uptake above background; 2, uptake mediastinum; 3, uptake mediastinum but liver; 4, uptake moderately liver; 5, uptake markedly higher than liver and/or new lesions.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=5 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=10 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Complete Response Rate (CRR) Cycle 3	11.9 Percentage of participants Interval 4.0 to 25.6	22.7 Percentage of participants Interval 11.5 to 37.8
Complete Response Rate (CRR) Cycle 6	11.9 Percentage of participants Interval 4.0 to 25.6	15.9 Percentage of participants Interval 6.6 to 30.1

SECONDARY outcome

Timeframe: From randomization to the date of first documented disease progression, relapse (local assessment) or death from any cause (up to approximately 27 months)

Population: CR or PR responders in Intent-to-Treat population This endpoint is a pre-specified analysis intended to combine all investigator's choice participants, regardless of the specific investigator's choice treatment that was administered.

Duration of response is defined as the time from attainment of complete response (CR) or partial response (PR) per local assessment to the date of first documented disease progression, relapse (local assessment) or death from any cause. Participants alive and free of progression will be censored at their last visit with adequate assessment.CR: complete metabolic response or computed tomography (CT)-based CR; PR: partial metabolic response or CT-based PR before subsequent anti-lymphoma therapy.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=17 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=19 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Duration of Response (DOR)	10.4 Percentage of participants Interval 2.56 to Upper limit not calculated due to insufficient number of events	3.4 Percentage of participants Interval 2.0 to Upper limit not calculated due to insufficient number of events

SECONDARY outcome

Timeframe: From randomization to the date of attainment of complete response (CR) or partial response (PR) until end of treatment (up to approximately 37 months)

Time to response is defined as the time from randomization to the date of attainment of complete response (CR) or partial response (PR) per local assessment until end of treatment. If a participant is not responder, time to response will be censored at the time of last visit with adequate assessment. CR: complete metabolic response or computed tomography (CT)-based CR; PR: partial metabolic response or CT-based PR before subsequent anti-lymphoma therapy.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=17 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=19 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Time to Response (TTR)	3 Months Interval 3.0 to 6.0	2.7 Months Interval 1.0 to 4.0

SECONDARY outcome

Timeframe: From randomization to objective tumor progression on next-line treatment or death from any cause (up to approximately 27 months)

PFS2 based on local assessment is defined as the time from randomization to objective tumor progression on next-line treatment or death from any cause. Participants without next-line therapy who did not die and participants who did not relapse or not die after next-line therapy will be censored at the last adequate tumor assessment date.

Outcome measures

Outcome measures
Measure	Oral Azacitidine n=42 Participants Participants received either safety run-in treatment or study treatment. In the safety run-in, participants received either 100 mg or 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT). Study treatment was either 300 mg daily for 14 days of 28-day cycle or 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, participant decision or unacceptable toxicity.	Investigators Choice Therapy Combined (Romidepsin, Bendamustine, Gemcitabine) n=44 Participants Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 (Japanese participants) or 1200 mg/m2 (EU participants) administered on days 1, 8, and 15 of each cycle.
Progression Free Survival 2 (PFS2) on Local Assessment	11.0 Months Interval 6.44 to 18.89	6.7 Months Interval 3.52 to 9.56

SECONDARY outcome

Timeframe: At baseline and on Day 1 of each cycle up to treatment discontinuation (up to approximately 27 months)

The minimal important difference (MID) is the size of difference in Quality-of-Life score that is considered relevant (i.e. warranting a change in treatment or examinations). The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQC30) subscale values are the lower threshold for MID over time, based on within-group mean change. QLQ-C30 has 5 functional scales (physical, role, emotional, cognitive, social), 3 symptom scales (fatigue, nausea/vomiting, pain), a global health status / quality of life (QoL) scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, financial difficulties). Each scale was scored on a range from 0 to 100. Higher scores represent a higher response level. Note that a high score for global health status or for a functional scale represents a high or healthy level of functioning, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

Outcome measures

Outcome data not reported

Adverse Events

Oral Azacitidine: 200 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 6 deaths

Oral Azacitidine: 300 mg

Serious events: 9 serious events

Other events: 33 other events

Deaths: 20 deaths

Investigators Choice Therapy - Romidepsin

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Investigators Choice Therapy - Bendamustine

Serious events: 8 serious events

Other events: 16 other events

Deaths: 13 deaths

Investigators Choice Therapy - Gemcitabine: 1000 mg/m2

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Investigators Choice Therapy - Gemcitabine: 1200 mg/m2

Serious events: 9 serious events

Other events: 19 other events

Deaths: 14 deaths

Safety Run-in Oral Azacitidine: 100 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 1 deaths

Safety Run-in Oral Azacitidine: 200 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Oral Azacitidine: 200 mg n=8 participants at risk Participants received 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, subject decision or unacceptable toxicity.	Oral Azacitidine: 300 mg n=34 participants at risk Participants received 300 mg daily for 14 days of 28-day cycle. Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, subject decision or unacceptable toxicity.	Investigators Choice Therapy - Romidepsin n=4 participants at risk Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Bendamustine n=16 participants at risk Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle	Investigators Choice Therapy - Gemcitabine: 1000 mg/m2 n=3 participants at risk Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Gemcitabine: 1200 mg/m2 n=20 participants at risk Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1200 mg/m2 administered on days 1, 8, and 15 of each cycle	Safety Run-in Oral Azacitidine: 100 mg n=3 participants at risk In the safety run-in, participants received 100 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT)	Safety Run-in Oral Azacitidine: 200 mg n=3 participants at risk In the safety run-in, participants received 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT)
Blood and lymphatic system disorders Febrile bone marrow aplasia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	18.8% 3/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Cardiac disorders Acute coronary syndrome	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Cardiac disorders Cardiac failure	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Constipation	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Chest pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Death	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Pyrexia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Immune system disorders Drug hypersensitivity	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Immune system disorders Haemophagocytic lymphohistiocytosis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Aspergillus infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Bacteraemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Bacterial sepsis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Bronchopulmonary aspergillosis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations COVID-19	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Cellulitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Clostridium colitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Cytomegalovirus infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Endocarditis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Enterovirus infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Epstein-Barr virus infection reactivation	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Pneumonia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Sepsis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Septic shock	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Sinusitis aspergillus	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Staphylococcal sepsis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Systemic candida	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Tonsillitis streptococcal	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Visceral leishmaniasis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder cancer	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Epstein-Barr virus associated lymphoma	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Nervous system disorders Paralysis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Renal and urinary disorders Acute kidney injury	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Peripheral ischaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Phlebitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)

Other adverse events

Other adverse events
Measure	Oral Azacitidine: 200 mg n=8 participants at risk Participants received 200 mg daily for 14 days of 28-day cycle (Japanese participants). Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, subject decision or unacceptable toxicity.	Oral Azacitidine: 300 mg n=34 participants at risk Participants received 300 mg daily for 14 days of 28-day cycle. Oral azacitidine was self-administered on the first 14 days of each 28-day treatment cycle, unless there was a schedule modification due to disease progression, subject decision or unacceptable toxicity.	Investigators Choice Therapy - Romidepsin n=4 participants at risk Single-agent Investigator's Choice Therapy - Romidepsin. Participants will receive treatment on a 28 day cycle with 14 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Bendamustine n=16 participants at risk Single-agent Investigator's Choice Therapy - Bendamustine. Participants will receive treatment on a 21-day cycle with 120 mg/m2 administered on days 1 and 2 of each cycle	Investigators Choice Therapy - Gemcitabine: 1000 mg/m2 n=3 participants at risk Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1000 mg/m2 administered on days 1, 8, and 15 of each cycle	Investigators Choice Therapy - Gemcitabine: 1200 mg/m2 n=20 participants at risk Single-agent Investigator's Choice Therapy - Gemcitabine. Participants will receive treatment on a 28-day cycle with 1200 mg/m2 administered on days 1, 8, and 15 of each cycle	Safety Run-in Oral Azacitidine: 100 mg n=3 participants at risk In the safety run-in, participants received 100 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT)	Safety Run-in Oral Azacitidine: 200 mg n=3 participants at risk In the safety run-in, participants received 200 mg daily of oral azacitidine for 14 days in a 28-day schedule and observed for dose limiting toxicities (DLT)
Blood and lymphatic system disorders Anaemia	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	29.4% 10/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	45.0% 9/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	50.0% 2/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	100.0% 3/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Lymphopenia	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	44.1% 15/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	75.0% 3/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	87.5% 14/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	100.0% 3/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	75.0% 15/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	66.7% 2/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Neutropenia	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	44.1% 15/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	75.0% 3/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	56.2% 9/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	66.7% 2/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	55.0% 11/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	66.7% 2/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Blood and lymphatic system disorders Thrombocytopenia	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	20.6% 7/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	100.0% 4/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	43.8% 7/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	66.7% 2/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	40.0% 8/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Cardiac disorders Tachycardia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Abdominal pain upper	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Aphthous ulcer	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Constipation	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	32.4% 11/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Dental caries	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Diarrhoea	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	26.5% 9/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 5/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	100.0% 3/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Dyspepsia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Nausea	62.5% 5/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	50.0% 17/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	50.0% 2/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	31.2% 5/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	30.0% 6/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Proctalgia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Retching	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Stomatitis	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	50.0% 2/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Gastrointestinal disorders Vomiting	50.0% 4/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	41.2% 14/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	100.0% 3/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Asthenia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	23.5% 8/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	18.8% 3/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	15.0% 3/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Catheter site pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Fatigue	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Injection site reaction	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Malaise	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Oedema peripheral	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
General disorders Pyrexia	37.5% 3/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 5/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Hepatobiliary disorders Hepatic function abnormal	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Immune system disorders Contrast media allergy	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Bronchitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations COVID-19	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Clostridium difficile infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Conjunctivitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Cytomegalovirus infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Erysipelas	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Fungal infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Furuncle	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Gingivitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Haemophilus infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Oral herpes	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Periodontitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Pharyngitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Pneumocystis jirovecii pneumonia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Pneumonia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Rhinitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Sinusitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Skin infection	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Systemic candida	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Tinea infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Infections and infestations Urinary tract infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Injury, poisoning and procedural complications Dental restoration failure	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Injury, poisoning and procedural complications Infusion related reaction	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Alanine aminotransferase increased	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Blood bilirubin increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Blood fibrinogen decreased	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Cytomegalovirus test positive	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Gamma-glutamyltransferase increased	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Platelet count decreased	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Investigations Weight decreased	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	8.8% 3/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hyperkalaemia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypoalbuminaemia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypokalaemia	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hyponatraemia	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Hypophosphataemia	25.0% 2/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Metabolism and nutrition disorders Malnutrition	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Musculoskeletal and connective tissue disorders Arthralgia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	8.8% 3/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Nervous system disorders Headache	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Nervous system disorders Neuropathy peripheral	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	8.8% 3/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Psychiatric disorders Depression	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Psychiatric disorders Insomnia	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Renal and urinary disorders Dysuria	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Renal and urinary disorders Pollakiuria	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Renal and urinary disorders Renal impairment	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Renal and urinary disorders Urethral pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	11.8% 4/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Decubitus ulcer	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.9% 2/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	18.8% 3/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Rash	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	11.8% 4/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	10.0% 2/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Seborrhoeic dermatitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	12.5% 2/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	33.3% 1/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Toxic skin eruption	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	2.9% 1/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Surgical and medical procedures Cataract operation	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Capillary leak syndrome	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	6.2% 1/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Circulatory collapse	12.5% 1/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Hypertension	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)
Vascular disorders Phlebitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/34 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	25.0% 1/4 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/16 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	5.0% 1/20 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)	0.00% 0/3 • Participants were assessed for all-cause mortality from their enrollment to study completion, (up to approximately 37 months). SAEs and Other AEs were assessed from first dose to 28 days following last dose (up to approximately 38 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 855-907-3286

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
Publication restrictions are in place

Restriction type: OTHER