Trial Outcomes & Findings for An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma (NCT NCT05251948)

NCT ID: NCT05251948

Last Updated: 2026-04-15

Results Overview

ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions, ≥ 4 weeks apart during Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \< 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters (SOD) of all target lesions, taking as reference the baseline SOD, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. Percentages have been rounded off.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

40 participants

Primary outcome timeframe

Up to 42.1 months

Results posted on

2026-04-15

Participant Flow

A total of 40 participants with inoperable locally advanced, metastatic, or advanced gastric carcinoma (GC) or gastroesophageal junction carcinoma (GEJC), who had not received prior systemic therapy for advanced or metastatic disease, took part in the study at 11 investigative sites in China from 01 March 2022 to 04 September 2025.

Participants in Stage 1 were randomized to receive either atezolizumab (atezo) in combination with capecitabine and oxaliplatin (CAPOX) (control arm), or atezolizumab in combination with CAPOX and tiragolumab (tira) (experimental arm). As pre-specified in the Protocol, the sponsor decided not to open the Stage 2 part of the study for enrollment.

Participant milestones

Participant milestones
Measure	Atezo + CAPOX Participants received atezolizumab, 1200 milligrams (mg), intravenously (IV) on Day 1 of each cycle, followed by capecitabine, 1000 milligrams per square meter (mg/m\^2), orally (PO), twice daily (BID), on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (1 Cycle=21 days). After completing Stage 1, participants entered the long-term survival follow-up (LTSFU).	Atezo + CAPOX + Tira Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Stage 1 STARTED	18	22
Stage 1 COMPLETED	17	17
Stage 1 NOT COMPLETED	1	5
Long-term Survival Follow-up STARTED	17	17
Long-term Survival Follow-up COMPLETED	0	0
Long-term Survival Follow-up NOT COMPLETED	17	17

Reasons for withdrawal

Reasons for withdrawal
Measure	Atezo + CAPOX Participants received atezolizumab, 1200 milligrams (mg), intravenously (IV) on Day 1 of each cycle, followed by capecitabine, 1000 milligrams per square meter (mg/m\^2), orally (PO), twice daily (BID), on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) (1 Cycle=21 days). After completing Stage 1, participants entered the long-term survival follow-up (LTSFU).	Atezo + CAPOX + Tira Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Stage 1 Death	0	3
Stage 1 Study Terminated by Sponsor	0	2
Stage 1 Withdrawal by Subject	1	0
Long-term Survival Follow-up Death	13	15
Long-term Survival Follow-up Study Terminated by Sponsor	3	2
Long-term Survival Follow-up Withdrawal by Subject	1	0

Baseline Characteristics

An Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Gastric or Gastroesophageal Junction Carcinoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.	Total n=40 Participants Total of all reporting groups	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Age, Continuous	59.45 years STANDARD_DEVIATION 11.49 • n=193 Participants	61.43 years STANDARD_DEVIATION 10.48 • n=386 Participants	63.83 years STANDARD_DEVIATION 8.80 • n=193 Participants
Sex: Female, Male Female	5 Participants n=193 Participants	8 Participants n=386 Participants	3 Participants n=193 Participants
Sex: Female, Male Male	17 Participants n=193 Participants	32 Participants n=386 Participants	15 Participants n=193 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=193 Participants	18 Participants n=386 Participants	8 Participants n=193 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	12 Participants n=193 Participants	22 Participants n=386 Participants	10 Participants n=193 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Race (NIH/OMB) Asian	22 Participants n=193 Participants	40 Participants n=386 Participants	18 Participants n=193 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Race (NIH/OMB) Black or African American	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Race (NIH/OMB) White	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants
Race (NIH/OMB) More than one race	0 Participants n=193 Participants	0 Participants n=386 Participants	0 Participants n=193 Participants

PRIMARY outcome

Timeframe: Up to 42.1 months

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Objective Response Rate (ORR)	55.6 percentage of participants Interval 30.76 to 78.47	40.9 percentage of participants Interval 20.71 to 63.65

SECONDARY outcome

Timeframe: From randomization to first occurrence of PD or death from any cause, whichever occurred first (up to 42.1 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

PFS after randomization was defined as the time from randomization to the first occurrence of PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. PFS was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median PFS was estimated using the Kaplan-Meier (K-M) method.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Progression-free Survival (PFS) After Randomization	9.51 months Interval 6.97 to 13.08	6.65 months Interval 4.93 to 9.2

SECONDARY outcome

Timeframe: From randomization to death from any cause (up to 42.1 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

OS was defined as the time from randomization to death from any cause, regardless of stage. Participants who were still alive at the time of OS analysis were censored at the last date they were known to be alive. Median OS was estimated using the K-M method.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Overall Survival (OS) After Randomization	20.85 months Interval 11.04 to 26.28	12.67 months Interval 6.6 to 15.67

SECONDARY outcome

Timeframe: At Months 6 and 12

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

OS was defined as the time from randomization to death from any cause, regardless of stage. OS rate at 6 and 12 months was defined as the percentage of participants who did not experience death from any cause at these timepoints from randomization. OS rates at the specified timepoints were estimated using the K-M method. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
OS Rates at Specified Timepoints Month 6	93.75 percentage of participants Interval 81.89 to 100.0	86.36 percentage of participants Interval 72.02 to 100.0
OS Rates at Specified Timepoints Month 12	68.75 percentage of participants Interval 46.04 to 91.46	50.00 percentage of participants Interval 29.11 to 70.89

SECONDARY outcome

Timeframe: From first occurrence of CR or PR to PD or death from any cause, whichever occurred first (up to 42.1 months)

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen. Overall number analyzed is the number of participants with OR (CR/PR).

DOR was defined as time from the first occurrence of a documented objective response (OR), CR or PR to PD or death from any cause (whichever occurred first) in Stage 1, as determined by the investigator according to RECIST v1.1. CR was defined as disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target/non-target lesions) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. DOR was censored at the day of the last tumor assessment for participants who did not die or did not have documented PD. Median DOR was estimated using the K-M method.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=10 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=9 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Duration of Response (DOR)	10.38 months Interval 5.62 to 20.37	8.08 months Interval 4.14 to 21.98

SECONDARY outcome

Timeframe: Up to 42.1 months

Population: Efficacy-evaluable population included all participants who received at least one dose of each drug for their assigned treatment regimen.

DCR was defined as percentage of participants with stable disease (SD) for ≥ 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1. SD was defined as neither sufficient shrinkage to qualify for CR or PR nor sufficient increase to qualify for PD. CR was defined as the disappearance of all target or non-target lesions. Any pathological lymph nodes (whether target or non-target lesions) must have a reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the SOD of all target lesions, taking as reference the baseline SOD, in the absence of CR. PD was defined as at least a 20% increase in the SOD of target lesions, taking as reference the smallest SOD at prior timepoints (including baseline) or unequivocal progression of existing non-target lesions. Additionally, the SOD must also demonstrate an absolute increase of ≥ 5 mm. Percentages have been rounded off.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Disease Control Rate (DCR)	77.8 percentage of participants Interval 52.36 to 93.59	72.7 percentage of participants Interval 49.78 to 89.27

SECONDARY outcome

Timeframe: Up to 42.1 months

Population: Safety-evaluable (SE) population included all participants who received any amount of the study treatment.

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Outcome measures

Outcome measures
Measure	Atezo + CAPOX n=18 Participants Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 Participants Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Number of Participants With Adverse Events (AEs)	18 Participants	22 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 42.1 months

Outcome measures

Outcome data not reported

Adverse Events

Atezo + CAPOX

Serious events: 9 serious events

Other events: 18 other events

Deaths: 13 deaths

Atezo + CAPOX + Tira

Serious events: 12 serious events

Other events: 22 other events

Deaths: 18 deaths

Serious adverse events

Other adverse events

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

Measure	Atezo + CAPOX n=18 participants at risk Participants received atezolizumab, 1200 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1 (1 Cycle=21 days). After completing Stage 1, participants entered the LTSFU.	Atezo + CAPOX + Tira n=22 participants at risk Participants received atezolizumab, 1200 mg, and tiragolumab, 600 mg, IV on Day 1 of each cycle, followed by capecitabine, 1000 mg/m\^2, PO, BID, on Days 1-14 of each cycle, and oxaliplatin 130 mg/m\^2, IV, on Day 1 of each cycle until unacceptable toxicity, or loss of clinical benefit, as determined by the investigator per RECIST v1.1. After completing Stage 1, participants entered the LTSFU.
Blood and lymphatic system disorders Anaemia	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Cardiac disorders Acute coronary syndrome	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Cardiac disorders Immune-mediated myocarditis	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Endocrine disorders Lymphocytic hypophysitis	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Ileus	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Immune-mediated enterocolitis	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Small intestinal obstruction	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Gastrointestinal disorders Vomiting	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Hepatobiliary disorders Autoimmune hepatitis	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Hepatobiliary disorders Cholecystitis acute	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Hepatobiliary disorders Hepatic failure	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Hepatobiliary disorders Jaundice	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Infections and infestations COVID-19	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Infections and infestations COVID-19 pneumonia	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Infections and infestations Herpes zoster	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Infections and infestations Pneumonia	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	9.1% 2/22 • Number of events 2 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Metabolism and nutrition disorders Decreased appetite	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Nervous system disorders Altered state of consciousness	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Renal and urinary disorders Haematuria	0.00% 0/18 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	4.5% 1/22 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.
Vascular disorders Aortic dilatation	5.6% 1/18 • Number of events 1 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.	0.00% 0/22 • Up to 42.1 months SE population included all participants who received any amount of the study treatment.