Trial Outcomes & Findings for A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction (NCT NCT04661150)
NCT ID: NCT04661150
Last Updated: 2026-01-30
Results Overview
pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist..
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
Completion of neoadjuvant systemic therapy (up to approximately 16 months)
Results posted on
2026-01-30
Participant Flow
Participant milestones
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
21
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
21
|
21
|
Reasons for withdrawal
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
Overall Study
Ongoing in study
|
19
|
20
|
|
Overall Study
Refused surgery and for personal reasons.
|
0
|
1
|
|
Overall Study
Death
|
2
|
0
|
Baseline Characteristics
A Study of Atezolizumab and Trastuzumab in Combination With Capecitabine and Oxaliplatin in Patients With HER2 Positive Locally Advanced Resectable Gastric Cancer of Adenocarcinoma of Gastroesophageal Junction
Baseline characteristics by cohort
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.9 Years
STANDARD_DEVIATION 9.03 • n=35 Participants
|
63.2 Years
STANDARD_DEVIATION 6.28 • n=4328 Participants
|
61.5 Years
STANDARD_DEVIATION 7.86 • n=8687 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=35 Participants
|
1 Participants
n=4328 Participants
|
3 Participants
n=8687 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=35 Participants
|
20 Participants
n=4328 Participants
|
39 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=35 Participants
|
21 Participants
n=4328 Participants
|
42 Participants
n=8687 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=35 Participants
|
0 Participants
n=4328 Participants
|
0 Participants
n=8687 Participants
|
PRIMARY outcome
Timeframe: Completion of neoadjuvant systemic therapy (up to approximately 16 months)Population: Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery.
pCR is defined as no evidence of vital residual tumor cells on hematoxylin and eosin evaluation of the complete resected gastric/GEJ specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy (NAST), which will be reviewed by local pathologist..
Outcome measures
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
Pathological Complete Regression (pCR) Rate
|
38.1 Percentage of Participants
Interval 18.1 to 61.6
|
14.3 Percentage of Participants
Interval 3.0 to 36.3
|
SECONDARY outcome
Timeframe: Randomization to the first documented disease recurrence, unequivocal tumor progression or death from any cause, whichever occurs first (up to approximately 52 months)Event-free survival (EFS), defined as the time from randomization to the first documented disease recurrence, unequivocal tumor progression determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Surgery to first documented disease recurrence or death from any cause, whichever occurs first (up to approximately 52 months)Disease-free survival (DFS), defined as the time from surgery to the first documented disease recurrence or death from any cause, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomiation to death from any cause (up to approximately 52 months)Overall survival (OS), defined as the time from randomization to death from any cause in all patients.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomization up to approximately 16 monthsMajor pathologic response (MPR), defined as \< 10% residual tumor per tumor bed based on evaluation of the resected primary esophagogastric specimen by a local pathologist.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Randomiation to CR or PR during neoadjuvant systemic therapy (up to approximately 16 months)Population: Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery.
Objective response rate (ORR), defined as the proportion of patients with a complete response (CR) or partial response (PR) during NAST, as determined by the investigator according to RECIST v1.1.
Outcome measures
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
Objective Response Rate (ORR)
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
33.3 Percentage of participants
Interval 14.6 to 57.0
|
SECONDARY outcome
Timeframe: SurgeryPopulation: Intention-to-treat (ITT) population, defined as all participants who were randomly assigned to a treatment, regardless of whether they had surgery.
R0 resection rate, defined as the proportion of patients with a microscopically margin-negative resection, in which no gross or microscopic tumor remains in the primary tumor bed and/or sampled regional lymph nodes based on evaluation by the local pathologist.
Outcome measures
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 Participants
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
R0 Resection Rate
|
95.2 Percentage of particpants
Interval 76.2 to 99.9
|
90.5 Percentage of particpants
Interval 69.6 to 98.8
|
SECONDARY outcome
Timeframe: Baseline through the end of study (approximately 52 months)Outcome measures
Outcome data not reported
Adverse Events
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 2 deaths
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm A: Atezolizumab Plus Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 participants at risk
Participants received atezolizumab + trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
Arm B: Trastuzumab With XELOX (Capecitabine + Oxaliplatin)
n=21 participants at risk
Participants received trastuzumab + XELOX (Capecitabine + Oxaliplatin) for 3 treatment cycles prior to surgery, each cycle is 3 weeks. Following surgery, participants received 5 further cycles of this regimen.
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
19.0%
4/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Gingival bleeding
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Ileus
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Platelet count decreased
|
19.0%
4/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
23.8%
5/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Weight decreased
|
19.0%
4/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Bilirubin conjugated increased
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood bilirubin increased
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Neutrophil count decreased
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Alanine aminotransferase increased
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Aspartate aminotransferase increased
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood bilirubin unconjugated increased 2
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
White blood cell count decreased
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Amylase increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood albumin decreased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood creatinine increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood glucose increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood pressure increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood urea increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Haemoglobin decreased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Neutrophil count increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
PCO2 decreased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
PO2 decreased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Protein total decreased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
White blood cell count increased
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Heart rate decreased
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Investigations
Weight increased
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
19.0%
4/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Asthenia
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Pyrexia
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Chills
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Face oedema
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Malaise
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
General disorders
Peripheral swelling
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
3/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Angina pectoris
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Coronary artery disease
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Cardiac disorders
Sinus arrhythmia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Pneumonia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Infections and infestations
Post procedural infection
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Wound complication
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Paraesthesia
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Taste disorder
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Nervous system disorders
Anaesthesia
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Endocrine disorders
Hyperthyroidism
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
9.5%
2/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Hypertension
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Vascular disorders
Hypotension
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.8%
1/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
0.00%
0/21 • From the first study drug to the data cutoff date: 21 March 2022 (up to approximately 12 months)
Serious \& other adverse events reported based on safety population, which included patients who received any amount of any component of study treatment. All-cause mortality reported for deaths that occurred during study based on ITT, which included all randomized patients.
|
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