Trial Outcomes & Findings for Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma (NCT NCT04091217)
NCT ID: NCT04091217
Last Updated: 2024-10-24
Results Overview
ORR was defined as the percentage of participants with a complete response (CR) defined as disappearance of all target lesions, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR, on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Up to approximately 32 months
Results posted on
2024-10-24
Participant Flow
This study was conducted at 3 centers in China.
There were 20 participants who died during the follow-up period who were recorded as study completed as per the protocol.
Participant milestones
| Measure |
Atezolizumab + Bevacizumab
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Overall Study
STARTED
|
43
|
|
Overall Study
Stage I Analysis Population
|
22
|
|
Overall Study
Stage II Analysis Population
|
38
|
|
Overall Study
COMPLETED
|
41
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Atezolizumab + Bevacizumab
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Overall Study
Lost to Follow-up
|
2
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Baseline Characteristics
Atezolizumab in Combination With Bevacizumab in Patients With Unresectable Locally Advanced or Metastatic Mucosal Melanoma
Baseline characteristics by cohort
| Measure |
Atezolizumab + Bevacizumab
n=43 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Age, Continuous
|
61.0 Years
n=93 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
43 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 32 monthsPopulation: Full Analysis Set (FAS) is defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints.
ORR was defined as the percentage of participants with a complete response (CR) defined as disappearance of all target lesions, or partial response (PR) defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR, on two consecutive occasions \>= 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=40 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Objective Response Rate (ORR) in the Full Analysis Set Analysis Population
|
45.0 Percentage of participants
Interval 29.26 to 61.51
|
SECONDARY outcome
Timeframe: Up to approximately 32 monthsPopulation: Full Analysis Set (FAS) is defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints.
PFS was defined as the time from the date of first treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=40 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Progression-Free Survival (PFS)
|
8.21 Months
Interval 4.07 to 9.59
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SECONDARY outcome
Timeframe: Up to approximately 32 monthsPopulation: Full Analysis Set (FAS) was defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints.
Overall survival was defined as the time from the date of first treatment to death from any cause.
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=40 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Overall Survival (OS)
|
24.77 Months
Interval 14.88 to
The upper limit of the 95% confidence interval could not be estimated because there was an insufficient number of participants with events.
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SECONDARY outcome
Timeframe: Up to approximately 32 monthsPopulation: Only responders (CR/PR) assessed by investigator were included in the analysis.
DOR was defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=18 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Duration of Objective Response (DOR)
|
12.42 Months
Interval 5.59 to 14.03
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SECONDARY outcome
Timeframe: Up to approximately 32 monthsPopulation: Full Analysis Set (FAS) was defined as all enrolled participants who receive any amount of study treatment and evaluable for efficacy endpoints.
DCR was defined as the sum of a complete or partial response or stable disease rates as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=40 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Disease Control Rate (DCR)
|
65.0 Percentage of Participants
Interval 48.32 to 79.37
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SECONDARY outcome
Timeframe: From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)Population: Safety analysis set is defined as all enrolled participants who receive any amount of least one dose of any study treatment.
The percentage of participants who experienced an Adverse Event (AE) or Serious Adverse Event (SAE). Incidence, nature, and severity of Adverse Events (AE), are reported per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0).
Outcome measures
| Measure |
Atezolizumab + Bevacizumab
n=43 Participants
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
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Percentage of Participants With Adverse Events
Percentage of participants with at least one AE by worst grade - Grade 2
|
27.9 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least 1 AE
|
95.3 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least one Grade 3-5 AE
|
25.6 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least one AE by worst grade - Grade 1
|
41.9 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least one AE by worst grade - Grade 3
|
23.3 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least one AE by worst grade - Grade 4
|
0 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage of participants with at least one AE by worst grade - Grade 5
|
2.3 Percentage of participants
|
|
Percentage of Participants With Adverse Events
Percentage with at least one SAE
|
20.9 Percentage of participants
|
Adverse Events
Atezolizumab + Bevacizumab
Serious events: 9 serious events
Other events: 34 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Atezolizumab + Bevacizumab
n=43 participants at risk
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
|
|---|---|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
4.7%
2/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Abdominal infection
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2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Hypophysitis
|
4.7%
2/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Appendicitis
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Infections and infestations
Orbital infection
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Epilepsy
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Gastrointestinal perforation
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Renal and urinary disorders
Hydronephrosis
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Autoimmune lung disease
|
2.3%
1/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
Other adverse events
| Measure |
Atezolizumab + Bevacizumab
n=43 participants at risk
Participants received 1200 mg atezolizumab by intravenous infusion every 3 weeks and/or 7.5 mg/kg bevacizumab by intravenous infusion every 3 weeks until unacceptable toxicity or loss of clinical benefit as determined by the investigator. Participants who transiently withheld or permanently discontinued either atezolizumab or bevacizumab may continue on single-agent therapy as long as the participants were experiencing clinical benefit in the opinion of the investigator.
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|---|---|
|
Investigations
Blood lactate dehydrogenase increased
|
37.2%
16/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood cholesterol increased
|
25.6%
11/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Aspartate aminotransferase increased
|
23.3%
10/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
20.9%
9/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood triglycerides increased
|
20.9%
9/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood bilirubin increased
|
18.6%
8/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood creatine phosphokinase increased
|
16.3%
7/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood uric acid increased
|
16.3%
7/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
14.0%
6/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood glucose increased
|
11.6%
5/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
White blood cell count decreased
|
11.6%
5/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Bilirubin conjugated increased
|
9.3%
4/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Weight decreased
|
9.3%
4/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood bilirubin unconjugated increased
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Blood urea increased
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Neutrophil count decreased
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Platelet count decreased
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Investigations
Protein urine present
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Pyrexia
|
20.9%
9/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
General disorders
Fatigue
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
11.6%
5/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Constipation
|
11.6%
5/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Gastrointestinal disorders
Nausea
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.0%
6/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Hypothyroidism
|
18.6%
8/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Endocrine disorders
Hyperthyroidism
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Vascular disorders
Hypertension
|
11.6%
5/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
7.0%
3/43 • From the first study drug to the data cutoff date: 31 August 2022 (up to approximately 32 months)
All-cause mortality reported for deaths that occurred during study based on ITT, which included all participants. Serious \& other adverse events reported based on safety population, which included participants who received any amount of any component of study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER