Trial Outcomes & Findings for A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1) (NCT NCT02951767)

Last Updated: 2024-03-28

Results Overview

Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeters (mm). PR was defined as greater than or equal to (≥) 30 percent (%) decrease in sum of longest diameter (LD) of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% confidence interval (CI) was calculated using the Clopper-Pearson method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

119 participants

Primary outcome timeframe

Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)

Results posted on

2024-03-28

Participant Flow

The study is considered "Completed" because the planned study activities and analyses have been performed.

The analysis included data up to cutoff date 28 February 2023.

Participant milestones

Participant milestones
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 milligrams (mg) via intravenous (IV) on Day 1 of 21-day cycles until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria or unmanageable toxicity.
Overall Study STARTED	119
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	119

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 milligrams (mg) via intravenous (IV) on Day 1 of 21-day cycles until disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) criteria or unmanageable toxicity.
Overall Study Study Terminated By Sponsor	9
Overall Study Withdrawal by Subject	11
Overall Study Death	96
Overall Study Lost to Follow-up	2
Overall Study Physician Decision	1

Baseline Characteristics

A Study of Atezolizumab in Participants With Locally Advanced or Metastatic Urothelial Bladder Cancer (Cohort 1)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Age, Continuous	71.8 years STANDARD_DEVIATION 8.9 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	96 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until confirmed disease progression or death, whichever occurred first (assessed at every 9 weeks for the first 12 months, thereafter every 12 weeks until data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)

Population: Cohort 1 objective response-evaluable population included intent-to-treat (ITT) participants who had measurable disease per RECIST v1.1 at baseline. Cohort 1 ITT population included all participants from Cohort 1 who received any amount of study drug.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants With a Confirmed Objective Response of Complete Response (CR) or Partial Response (PR) as Assessed by the Independent Review Facility (IRF) According to RECIST v1.1	22.7 percentage of participants Interval 15.5 to 31.3

SECONDARY outcome

Population: Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.

DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the IRF according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=27 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Duration of Response (DOR) as Assessed by the IRF According to RECIST v1.1	NA months Interval 3.7 to The median DOR and upper limit for the Full Range were not reached at a median follow up of 17.216 months on study.

SECONDARY outcome

Population: Cohort 1 objective response-evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome.

DOR was defined as the time from the initial occurrence of documented CR or PR (whichever occurred first) until documented disease progression or death due to any cause on study, whichever occurred first. Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and no new measurable or unmeasurable lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=30 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
DOR as Assessed by the Investigator According to RECIST v1.1	NA months Interval 4.3 to The median DOR and upper limit for the Full Range were not reached at a median follow up of 17.216 months on study.

SECONDARY outcome

Population: Cohort 1 ITT population.

Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants With Death or Disease Progression as Assessed by the IRF According to RECIST v1.1	73.9 percentage of participants Interval 2.0 to

SECONDARY outcome

Population: Cohort 1 ITT population.

PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the IRF according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Progression-Free Survival (PFS) as Assessed by the IRF According to RECIST v1.1	2.69 months Interval 2.1 to 4.17

SECONDARY outcome

Population: Cohort 1 ITT population.

Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The percentage of participants who died or experienced PD was reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants With Death or Disease Progression as Assessed by the Investigator According to RECIST v1.1	71.4 percentage of participants Interval 2.0 to

SECONDARY outcome

Population: Cohort 1 ITT population.

PFS was defined as the time from start of treatment to the first event of death or PD. Tumor response was assessed by the investigator according to RECIST v1.1. Disease progression or PD was defined as ≥20% increase in sum LD in reference to the smallest on-study sum LD, or the appearance of new lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
PFS as Assessed by the Investigator According to RECIST v1.1	4.17 months Interval 2.3 to 5.75

SECONDARY outcome

Population: Cohort 1 objective response-evaluable population.

Tumor response was assessed by the investigator according to RECIST v1.1. CR was defined as disappearance of all target and non-target lesions and (if applicable) normalization of tumor marker levels. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined as ≥30% decrease in sum of LD of target lesions in reference to Baseline sum LD. Response was to be confirmed ≥4 weeks after the initial assessment of CR or PR. The percentage of participants with a confirmed objective response of CR or PR was reported. The exact 95% CI was calculated using the Clopper-Pearson method.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants With a Confirmed Objective Response of CR or PR as Assessed by the Investigator According RECIST v1.1	25.2 percentage of participants Interval 17.7 to 34.0

SECONDARY outcome

Timeframe: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)

Population: Cohort 1 ITT population.

The percentage of participants who died from any cause was reported.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants Who Died	49.6 percentage of participants Interval 15.52 to 31.27

SECONDARY outcome

Timeframe: Baseline until death (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)

Population: Cohort 1 ITT population.

OS was defined as the time from start of treatment to the time of death from any cause on study.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Overall Survival (OS)	15.9 months Interval 10.4 to The upper limit of the 95% CI was not calculable because an insufficient number of participants reached the event at the final time point for assessment.

SECONDARY outcome

Timeframe: 1-year

Population: Cohort 1 ITT population.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=119 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants Alive at 1-year	57.2 percentage of participants Interval 48.2 to 66.3

SECONDARY outcome

Timeframe: Pre-dose (0 hours) and 30 minutes post-dose on Day 1 of Cycle 1 (Cycle length = 21 days)

Population: Cohort 1 pharmacokinetic (PK) evaluable population was defined as participants who received any dose of atezolizumab treatment and had PK data at timepoints that were sufficient to determine PK parameters. Here, number of participants analyzed = participants who were evaluable for this outcome.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=113 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Maximum Serum Concentration (Cmax) of Atezolizumab	386 microgram(s)/milliliter (mcg/mL) Standard Deviation 118 • Interval 36.29 to 62.3

SECONDARY outcome

Timeframe: Pre-dose (0 hours) on Day 1 of Cycles 1, 2, 3, 4, 8 (Cycle length = 21 days)

Population: Cohort 1 PK evaluable population. Here, number of participants analyzed = participants who were evaluable for this outcome. "n" = participants who were evaluable at specified timepoint.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=117 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Minimum Serum Concentration (Cmin) of Atezolizumab Pre-dose Cycle 3 (n=57)	117 mcg/mL Standard Deviation 48.8
Minimum Serum Concentration (Cmin) of Atezolizumab Pre-dose Cycle 4 (n=66)	159 mcg/mL Standard Deviation 68.4
Minimum Serum Concentration (Cmin) of Atezolizumab Pre-dose Cycle 8 (n=47)	169 mcg/mL Standard Deviation 110
Minimum Serum Concentration (Cmin) of Atezolizumab Pre-dose Cycle 1 (n=117)	0 mcg/mL Standard Deviation 0 • Interval 36.29 to 62.3
Minimum Serum Concentration (Cmin) of Atezolizumab Pre-dose Cycle 2 (n=106)	77.7 mcg/mL Standard Deviation 35.3

SECONDARY outcome

Timeframe: Day 1 of all cycles (Cycle length = 21 days) and at treatment discontinuation (data cutoff date 04 July 2016, up to maximum length of follow-up of 23.52 months)

Population: Cohort 1 Safety Evaluable Population. Here, number of participants analyzed = participants for whom ATA samples were available.

Outcome measures

Outcome measures
Measure	Cohort 1: Treatment-naive Cisplatin Ineligible Participants n=111 Participants Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
Percentage of Participants Positive for Anti-therapeutic Antibodies (ATA) to Atezolizumab	47.7 percentage of participants 0 • Interval 36.29 to 62.3

Adverse Events

MPDL3280A COHORT1 INFUSION

Serious events: 49 serious events

Other events: 110 other events

Deaths: 96 deaths

Serious adverse events

Serious adverse events
Measure	MPDL3280A COHORT1 INFUSION n=119 participants at risk
Blood and lymphatic system disorders ANAEMIA	1.7% 2/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Blood and lymphatic system disorders LYMPH NODE PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders ARRHYTHMIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders ATRIAL FIBRILLATION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders CARDIAC ARREST	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders CARDIAC FAILURE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders MYOCARDIAL INFARCTION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Cardiac disorders PERICARDIAL EFFUSION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Ear and labyrinth disorders VERTIGO	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Endocrine disorders HYPOTHYROIDISM	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ABDOMINAL HERNIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ABDOMINAL PAIN	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ABDOMINAL PAIN LOWER	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ANAL INCONTINENCE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders AUTOIMMUNE COLITIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders COLITIS	1.7% 2/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders COLITIS ISCHAEMIC	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders DIARRHOEA	2.5% 3/119 • Number of events 5 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ILEUS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders INTESTINAL PERFORATION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders NAUSEA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	2.5% 3/119 • Number of events 3 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders SUBILEUS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders VOMITING	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders ASTHENIA	1.7% 2/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders CHILLS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders FATIGUE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders GAIT DISTURBANCE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders HAEMORRHAGIC CYST	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders MALAISE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders NON-CARDIAC CHEST PAIN	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders PERFORMANCE STATUS DECREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders PYREXIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders SYSTEMIC INFLAMMATORY RESPONSE SYNDROME	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Hepatobiliary disorders CHOLECYSTITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Hepatobiliary disorders HEPATITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Hepatobiliary disorders HYPERBILIRUBINAEMIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Hepatobiliary disorders LIVER DISORDER	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Immune system disorders HYPERSENSITIVITY	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations ABDOMINAL INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations BACTERAEMIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations BILIARY SEPSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations BRONCHITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations BURSITIS INFECTIVE STAPHYLOCOCCAL	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations CELLULITIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations CELLULITIS OF MALE EXTERNAL GENITAL ORGAN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations DEVICE RELATED INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations DIVERTICULITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations GASTROENTERITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations INFLUENZA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations KIDNEY INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations MENINGOENCEPHALITIS HERPETIC	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations PNEUMONIA	1.7% 2/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations POST PROCEDURAL INFECTION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations PULMONARY SEPSIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations PYELONEPHRITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations RETROPERITONEAL INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations SEPSIS	2.5% 3/119 • Number of events 3 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations SKIN INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations URINARY TRACT INFECTION	3.4% 4/119 • Number of events 4 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations URINARY TRACT INFECTION PSEUDOMONAL	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations UROSEPSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations VASCULAR DEVICE INFECTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications FALL	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications FRACTURE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications ILIUM FRACTURE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications JOINT INJURY	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications LOWER LIMB FRACTURE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications POST PROCEDURAL HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications STOMA SITE HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications TOXICITY TO VARIOUS AGENTS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM RUPTURED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations ALANINE AMINOTRANSFERASE INCREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD BILIRUBIN INCREASED	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD CREATINE PHOSPHOKINASE INCREASED	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD CREATININE INCREASED	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations PLATELET COUNT DECREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations WHITE BLOOD CELL COUNT DECREASED	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders DEHYDRATION	2.5% 3/119 • Number of events 3 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders FAILURE TO THRIVE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPERCALCAEMIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPERKALAEMIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPONATRAEMIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders ARTHRALGIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders BACK PAIN	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders BONE PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders FLANK PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders PATHOLOGICAL FRACTURE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders RHABDOMYOLYSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA PANCREAS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR ASSOCIATED FEVER	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders ATAXIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders CEREBRAL HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders CEREBROVASCULAR ACCIDENT	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders DIPLEGIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders ENCEPHALOPATHY	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders PARAPLEGIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders SYNCOPE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders TRANSIENT ISCHAEMIC ATTACK	0.84% 1/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Product Issues THROMBOSIS IN DEVICE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders CONFUSIONAL STATE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders DELIRIUM	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders HALLUCINATION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders MENTAL STATUS CHANGES	1.7% 2/119 • Number of events 2 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders ACUTE KIDNEY INJURY	3.4% 4/119 • Number of events 5 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders BLADDER PERFORATION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders CHRONIC KIDNEY DISEASE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders HAEMATURIA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders HYDRONEPHROSIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders HYDROURETER	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders RENAL FAILURE	2.5% 3/119 • Number of events 3 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders URETERIC OBSTRUCTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders URINARY RETENTION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders URINARY TRACT OBSTRUCTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Reproductive system and breast disorders PELVIC PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Reproductive system and breast disorders PENILE PAIN	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Reproductive system and breast disorders VAGINAL HAEMORRHAGE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders HICCUPS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders PULMONARY ARTERY THROMBOSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders RESPIRATORY DISTRESS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders DERMATITIS PSORIASIFORM	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders ERYTHEMA	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Social circumstances IMMOBILE	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Surgical and medical procedures RENAL STONE REMOVAL	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Surgical and medical procedures URETERAL STENT INSERTION	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Vascular disorders DEEP VEIN THROMBOSIS	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Vascular disorders EMBOLISM	0.00% 0/119 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Vascular disorders HAEMATOMA	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Vascular disorders HYPOTENSION	0.84% 1/119 • Number of events 1 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.

Other adverse events

Other adverse events
Measure	MPDL3280A COHORT1 INFUSION n=119 participants at risk
Blood and lymphatic system disorders ANAEMIA	21.0% 25/119 • Number of events 39 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Endocrine disorders HYPOTHYROIDISM	8.4% 10/119 • Number of events 10 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders ABDOMINAL PAIN	11.8% 14/119 • Number of events 15 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders CONSTIPATION	17.6% 21/119 • Number of events 35 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders DIARRHOEA	26.1% 31/119 • Number of events 50 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders NAUSEA	24.4% 29/119 • Number of events 35 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Gastrointestinal disorders VOMITING	20.2% 24/119 • Number of events 29 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders ASTHENIA	10.1% 12/119 • Number of events 18 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders CHILLS	9.2% 11/119 • Number of events 16 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders FATIGUE	53.8% 64/119 • Number of events 87 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders OEDEMA PERIPHERAL	19.3% 23/119 • Number of events 30 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders PAIN	5.9% 7/119 • Number of events 8 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
General disorders PYREXIA	17.6% 21/119 • Number of events 24 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	7.6% 9/119 • Number of events 13 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Infections and infestations URINARY TRACT INFECTION	17.6% 21/119 • Number of events 30 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations ALANINE AMINOTRANSFERASE INCREASED	8.4% 10/119 • Number of events 17 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	8.4% 10/119 • Number of events 26 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD ALKALINE PHOSPHATASE INCREASED	6.7% 8/119 • Number of events 12 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations BLOOD CREATININE INCREASED	18.5% 22/119 • Number of events 35 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations LYMPHOCYTE COUNT DECREASED	5.9% 7/119 • Number of events 13 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Investigations WEIGHT DECREASED	10.1% 12/119 • Number of events 13 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders DECREASED APPETITE	31.1% 37/119 • Number of events 46 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders DEHYDRATION	8.4% 10/119 • Number of events 10 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPERGLYCAEMIA	9.2% 11/119 • Number of events 21 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPERKALAEMIA	9.2% 11/119 • Number of events 19 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Metabolism and nutrition disorders HYPONATRAEMIA	10.1% 12/119 • Number of events 26 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders ARTHRALGIA	22.7% 27/119 • Number of events 45 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders BACK PAIN	16.0% 19/119 • Number of events 21 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	5.0% 6/119 • Number of events 6 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	5.0% 6/119 • Number of events 7 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	9.2% 11/119 • Number of events 17 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders DIZZINESS	8.4% 10/119 • Number of events 13 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders HEADACHE	10.9% 13/119 • Number of events 17 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Nervous system disorders NEUROPATHY PERIPHERAL	5.0% 6/119 • Number of events 6 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders ANXIETY	9.2% 11/119 • Number of events 12 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders CONFUSIONAL STATE	5.9% 7/119 • Number of events 10 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders DEPRESSION	5.9% 7/119 • Number of events 7 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Psychiatric disorders INSOMNIA	10.1% 12/119 • Number of events 12 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders DYSURIA	5.0% 6/119 • Number of events 6 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders HAEMATURIA	10.1% 12/119 • Number of events 15 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Renal and urinary disorders PROTEINURIA	5.0% 6/119 • Number of events 8 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Reproductive system and breast disorders PELVIC PAIN	5.9% 7/119 • Number of events 8 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders COUGH	21.0% 25/119 • Number of events 29 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	15.1% 18/119 • Number of events 18 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	5.9% 7/119 • Number of events 8 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders DRY SKIN	8.4% 10/119 • Number of events 10 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders PRURITUS	19.3% 23/119 • Number of events 39 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders RASH	11.8% 14/119 • Number of events 22 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Skin and subcutaneous tissue disorders RASH MACULO-PAPULAR	5.0% 6/119 • Number of events 6 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.
Vascular disorders HYPOTENSION	5.9% 7/119 • Number of events 8 • First dose of study drug until data cutoff date 28 February 2023 (up to approximately 105 months) All-Cause Mortality was assessed for all enrolled participants, Serious and Other Adverse Events were assessed in the safety population.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER