Trial Outcomes & Findings for A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer (NCT NCT04340193)
NCT ID: NCT04340193
Last Updated: 2024-11-26
Results Overview
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
26 participants
Primary outcome timeframe
From first dose and 30 days after last dose of study therapy (up to approximately 25 months)
Results posted on
2024-11-26
Participant Flow
Participant milestones
| Measure |
NIVO+IPI+TACE
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
9
|
8
|
|
Overall Study
COMPLETED
|
6
|
4
|
4
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
4
|
Reasons for withdrawal
| Measure |
NIVO+IPI+TACE
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Overall Study
Other reason
|
0
|
0
|
1
|
|
Overall Study
Disease recurrence
|
0
|
1
|
0
|
|
Overall Study
Study drug toxicity
|
1
|
0
|
0
|
|
Overall Study
Disease progression
|
1
|
2
|
3
|
|
Overall Study
Administrative reasons by sponsor
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
1
|
0
|
Baseline Characteristics
A Study of Nivolumab and Ipilimumab and Nivolumab Alone in Combination With Trans-arterial ChemoEmbolization (TACE) in Participants With Intermediate Stage Liver Cancer
Baseline characteristics by cohort
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
72.3 years
STANDARD_DEVIATION 10.28 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 11.19 • n=7 Participants
|
70.3 years
STANDARD_DEVIATION 8.89 • n=5 Participants
|
68.3 years
STANDARD_DEVIATION 10.70 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
5 participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
3 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Adverse Events
|
9 Participants
|
9 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose that results in death, Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) or requires inpatient hospitalization or causes prolongation of existing hospitalization, or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect or is an important medical event.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
7 Participants
|
6 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: From first dose and 100 days after last dose of study therapy (up to approximately 27 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
Number of participants who died due to any cause are summarized.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants Who Died
|
2 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Adverse Events Leading to Study Drug Discontinuation
|
3 Participants
|
1 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
Laboratory results were graded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Grade 3 =Severe, Grade 4 = Life-threatening). Highest grade measured for hemoglobin and albumin was Grade 3.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hemoglobin (Grade 3)
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Platelet count (Grade 3)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Platelet Count (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Leukocytes (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Leukocytes (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Lymphocytes (Grade 3)
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Lymphocytes (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Aspartate Aminotransferase (Grade 3)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Aspartate Aminotransferase (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Alanine Aminotransferase (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Alanine Aminotransferase (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Bilirubin, Total (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Bilirubin, TOTAL (Grade 4)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Creatinine, (Grade 3)
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Creatinine (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Potassium, (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Potassium (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Amylase (Grade 3)
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Amylase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Lipase (Grade 3)
|
4 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Lipase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Albumin, (Grade 3)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Absolute Neutrophil Count (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Absolute Neutrophil Count (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Alkaline Phosphatase (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Alkaline Phosphatase (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Sodium (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Sodium (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Calcium, Total (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Calcium, Total (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Magnesium (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Magnesium (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Glucose (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Glucose (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypernatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypernatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hyponatremia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hyponatremia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hyperkalemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hyperkalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypokalemia (Grade 3)
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypokalemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypercalcemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypercalcemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypermagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypermagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypomagnesemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypomagnesemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypoglycemia (Grade 3)
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Grade (Grade 3/4) Laboratory Results
Hypoglycemia (Grade 4)
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants with at least one on-treatment thyroid stimulating hormone (TSH) measurement.
Blood samples were collected for specific thyroid test.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN (Upper Limit of Normal)
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with TSH <= ULN at baseline
|
5 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with at least one FT3/FT4 test value < LLN (Lower Limit of Normal)
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with all other FT3/FT4 test values >= LLN
|
5 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with FT3/FT4 test missing
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with TSH >= LLN at baseline
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with at least one FT3/FT4 test value > ULN
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
With all other FT3/FT4 test values <= ULN
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
With FT3/FT4 test missing
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (up to approximately 25 months)Population: All treated participants included all enrolled participants who received at least one dose of any study treatment.
Blood samples were collected for specific liver tests.
Outcome measures
| Measure |
NIVO+IPI+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 Participants
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 Participants
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
ALT or AST > 5 X Upper limit of Normal (ULN)
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Alanine Transaminase (ALT) or AST > 10 X ULN
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
ALT or Aspartate Transaminase (AST) > 20 X ULN
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Total Bilirubin > 2 X ULN
|
3 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
ALP (Alkaline Phosphatase) > 1.5 X ULN
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT OR AST Elevation > 3 X ULN with total Bilirubin > 2 X ULN within one day
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinical Laboratory Abnormalities in Specific Liver Tests
Concurrent ALT or AST elevation > 3 X ULN with total Bilirubin > 2 X ULN within 30 days
|
3 Participants
|
2 Participants
|
0 Participants
|
Adverse Events
NIVO+IPI+TACE
Serious events: 7 serious events
Other events: 9 other events
Deaths: 2 deaths
NIVO+TACE
Serious events: 6 serious events
Other events: 9 other events
Deaths: 2 deaths
TACE
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
NIVO+IPI+TACE
n=9 participants at risk
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 participants at risk
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 participants at risk
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Non-cardiac chest pain
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Pyrexia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
33.3%
3/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Hepatobiliary disorders
Hepatic failure
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Hepatic infection
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
International normalised ratio increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Cell death
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
Other adverse events
| Measure |
NIVO+IPI+TACE
n=9 participants at risk
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab (NIVO) 240 milligram (mg) every 2 weeks (Q2W) and ipilimumab (IPI) 1 milligram per kilogram (mg/kg) every 6 weeks (Q6W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
|
NIVO+TACE
n=9 participants at risk
Participants with intermediate-stage hepatocellular carcinoma (HCC) received Nivolumab 240 milligram (mg) every 2 weeks (Q2W) as an approximately 30-minute infusion. Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
TACE
n=8 participants at risk
Participants received first Trans-arterial ChemoEmbolization (TACE) in 7 days after randomization and then TACE as needed, until participant was no longer eligible for further TACE, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first. Per Protocol Amendment 01, participants did not receive placebo infusions following unblinding.
|
|---|---|---|---|
|
Cardiac disorders
Cardiovascular disorder
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Cardiac disorders
Tachycardia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
33.3%
3/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Ascites
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Chronic gastritis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Constipation
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
50.0%
4/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Dental caries
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
3/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
37.5%
3/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Portal hypertensive gastropathy
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Stomatitis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Varices oesophageal
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Asthenia
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Device related thrombosis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Fatigue
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Feeling hot
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Inflammation
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Mucosal inflammation
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Oedema peripheral
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
37.5%
3/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
General disorders
Pyrexia
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
33.3%
3/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Bacteriuria
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
COVID-19
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Cystitis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Dermo-hypodermitis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Enteritis infectious
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Herpes simplex
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Influenza
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Pneumonia
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Pneumonia aspiration
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Respiratory tract infection
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Rhinitis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Urinary tract infection
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Bone contusion
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Craniofacial fracture
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Hepatobiliary procedural complication
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Post embolisation syndrome
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Skin injury
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Blood creatinine increased
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Gastric pH decreased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Inflammatory marker increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Lipase increased
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Lymphocyte count decreased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Oxygen saturation decreased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Weight decreased
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Investigations
Weight increased
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
37.5%
3/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Fluid retention
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Dizziness
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Encephalopathy
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Hepatic encephalopathy
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Psychiatric disorders
Insomnia
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Renal and urinary disorders
Dysuria
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Renal and urinary disorders
Haematuria
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
12.5%
1/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
3/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
44.4%
4/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
25.0%
2/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
22.2%
2/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
37.5%
3/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
|
Vascular disorders
Raynaud's phenomenon
|
11.1%
1/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/9 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
0.00%
0/8 • All-cause mortality was collected from randomization until their study completion (up to approximately 38 months). Serious and non-serious adverse events were collected from first dose to 100 days after last dose of study therapy (up to approximately 27 months).
All treated participants included all enrolled participants who received at least one dose of any study treatment.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication
- Publication restrictions are in place
Restriction type: OTHER