Trial Outcomes & Findings for A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02) (NCT NCT01989676)
NCT ID: NCT01989676
Last Updated: 2021-07-06
Results Overview
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
707 participants
Primary outcome timeframe
From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visit
Results posted on
2021-07-06
Participant Flow
A total of 707 participants were randomized to the study. Of these, 5 participants were randomized but did not receive the study drug.
Participants who fulfilled the inclusion/exclusion criteria were randomly assigned to 1 of the 2 treatments of this study.
Participant milestones
| Measure |
PF-05280014
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Overall Study
STARTED
|
352
|
355
|
|
Overall Study
Treated
|
349
|
353
|
|
Overall Study
COMPLETED
|
234
|
217
|
|
Overall Study
NOT COMPLETED
|
118
|
138
|
Reasons for withdrawal
| Measure |
PF-05280014
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Overall Study
Death
|
52
|
60
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
8
|
18
|
|
Overall Study
No longer willing to participate in study
|
26
|
26
|
|
Overall Study
Participants terminated from study by Sponsor
|
26
|
30
|
|
Overall Study
Other
|
4
|
3
|
Baseline Characteristics
A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02)
Baseline characteristics by cohort
| Measure |
PF-05280014
n=349 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=353 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Total
n=702 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<18
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18 to 64
|
283 Participants
n=5 Participants
|
292 Participants
n=7 Participants
|
575 Participants
n=5 Participants
|
|
Age, Customized
65 to 84
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Age, Customized
≥85
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
349 Participants
n=5 Participants
|
353 Participants
n=7 Participants
|
702 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until all participants had either completed the Week 33 tumor assessment or discontinued study drug earlier than the Week 33 visitPopulation: The ITT population was defined as all participants who were randomized to study drug.
ORR was defined as the percentage of participants who achieved complete response (CR, complete disappearance of all target lesions with the exception of nodal disease; all target nodes must have decreased to normal size \[short axis \<10 mm\]) or partial response (PR, \>=30% decrease from baseline of the sum of diameters (SOD) of all target measurable lesions; the short diameter was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions) by Week 25 of the study and confirmed on a follow-up assessment (Week 33+/-14 days), based on the assessments of the central radiology review in accordance with RECIST 1.1.
Outcome measures
| Measure |
PF-05280014
n=352 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=355 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Objective Response Rate (ORR) Derived From Central Radiology Assessments: ITT Population
|
62.5 percentage of participants
Interval 57.2 to 67.6
|
66.5 percentage of participants
Interval 61.3 to 71.4
|
SECONDARY outcome
Timeframe: From the date of randomization until 378 days post-randomizationPopulation: The ITT population was defined as all participants who were randomized to study drug.
One-year PFS rate was analyzed based on the time from date of randomization to first documentation of progressive disease (PD), or death due to any cause in the absence of documented PD, based on the assessments of the central radiology review in accordance with RECIST 1.1. PD was defined for target disease as at least a 20% increase in sum of diameters of target measurable lesions above the smallest sum observed (over baseline if no decrease in the sum was observed during therapy) with a minimum absolute increase of 5 mm. For non-target disease: PD was defined as unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for the median time to event was based on the Brookmeyer and Crowley method.
Outcome measures
| Measure |
PF-05280014
n=352 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=355 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
One-year Progression-Free Survival (PFS) Rate Derived From Central Radiology Assessments: ITT Population
|
12.16 months
Interval 11.93 to 12.48
|
12.06 months
Interval 11.79 to
There are insufficient events to estimate the upper bound of the 95% CI.
|
SECONDARY outcome
Timeframe: From the date of randomization until 378 days post-randomizationPopulation: The ITT population was defined as all participants who were randomized to study drug. Here "Overall number of participants analyzed" signifies participants evaluable for this outcome measure.
DOR:time from first documentation of objective response (CR or PR) to first documentation of PD/death due to any cause in absence of documented PD, based on central radiology review. As per RECIST v1.1, CR:complete disappearance of all target lesions with exception of nodal disease; all target nodes reduced in short axis \<10 mm. PR: \>=30% decrease from baseline of SOD of target lesions; short diameter used in sum for target nodes,longest diameter used in sum for other target lesions. PD for target disease:at least 20% increase in SOD of target lesions above smallest sum observed (over baseline if no decrease in sum observed) with minimum absolute increase of 5 mm. For non-target disease:unequivocal progression of pre-existing lesions and if overall tumor burden increased sufficiently to merit discontinuation of therapy; appearance of any new unequivocal malignant lesion was also considered PD. The 95% CI for median time to event was based on the Brookmeyer and Crowley method.
Outcome measures
| Measure |
PF-05280014
n=224 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=238 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Duration of Response (DOR) Per Central Radiology Assessments: ITT Population
|
11.27 months
Interval 10.41 to 11.27
|
10.58 months
Interval 10.22 to
There are insufficient events to estimate the upper bound of the 95% CI.
|
SECONDARY outcome
Timeframe: From the date of randomization until end of study (approximately 6 years)Population: The ITT population was defined as all participants who were randomized to study drug.
Overall survival was analyzed based on the time from date of randomization to the date of death due to any cause. Participants last known to be alive were censored on the date of last contact. The 95% CI for the median time to event was based on the Brookmeyer and Crowley Method.
Outcome measures
| Measure |
PF-05280014
n=352 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=355 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Overall Survival: ITT Population
|
NA months
There were insufficient events to estimate the median survival and the 95% CI.
|
NA months
There were insufficient events to estimate the median survival and the 95% CI.
|
SECONDARY outcome
Timeframe: 1 hour post end of infusion on Day 1 of Cycles 1 and 5Population: PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "number analyzed (n)" signifies participants evaluable at specified time points only.
Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
PF-05280014
n=349 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population
Cycle 1 Day 1
|
89.85 mcg/mL
Interval 0.0 to 246.0
|
—
|
|
Serum Peak Concentration of PF-05280014 at Selected Cycles: Pharmacokinetics (PK) Population
Cycle 5 Day 1
|
95.70 mcg/mL
Interval 0.0 to 435.0
|
—
|
SECONDARY outcome
Timeframe: 1 hour post end of infusion on Day 1 of Cycles 1 and 5Population: PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "n" signifies participants evaluable at specified time points only.
Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.
Outcome measures
| Measure |
PF-05280014
n=353 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 1 Day 1
|
89.70 mcg/mL
Interval 0.0 to 273.0
|
—
|
|
Serum Peak Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 5 Day 1
|
94.40 mcg/mL
Interval 8.96 to 353.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5Population: PK population.Here "n" signifies participants evaluable at specified time points only.The Cycle 17 Day 1 (C17D1) samples summarized previously at PCD (Week 33) fell outside of cut-off used for final analysis (Week 53), to limit data for up to 1-year post randomization, which was more conservative from previous Week 33 analysis. While comparing data between Week 33 and Week 53, there was a significant drop off in number of samples summarized at C17D1 and was down to zero for this outcome measure.
Human PK serum samples were analyzed for concentrations of PF-05280014 using a validated, sensitive, and specific ELISA.
Outcome measures
| Measure |
PF-05280014
n=349 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 1 Day 1
|
0.00 mcg/mL
Interval 0.0 to 123.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 1 Day 8
|
27.90 mcg/mL
Interval 0.0 to 91.5
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 3 Day 1
|
48.20 mcg/mL
Interval 0.0 to 110.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 4 Day 1
|
53.50 mcg/mL
Interval 0.0 to 150.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 5 Day 1
|
57.00 mcg/mL
Interval 0.0 to 182.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 5 Day 8
|
57.40 mcg/mL
Interval 9.85 to 174.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 7 Day 1
|
60.50 mcg/mL
Interval 0.0 to 152.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 8 Day 1
|
62.25 mcg/mL
Interval 0.0 to 140.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 11 Day 1
|
54.65 mcg/mL
Interval 0.0 to 148.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of PF-05280014 at Selected Cycles: PK Population
Cycle 14 Day 1
|
50.70 mcg/mL
Interval 0.0 to 189.0
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 4, 5, 7, 8, 11, 14, 17 and Day 8 of Cycles 1 and 5Population: PK population was used for analysis, included all participants who received PF-05280014 or trastuzumab-EU and had no major protocol deviations that influenced PK assessments, and had at least 1 post dose concentration measurement. Here "n" signifies participants evaluable at specified time points only.
Human PK serum samples were analyzed for concentrations of trastuzumab-EU using a validated, sensitive, and specific ELISA.
Outcome measures
| Measure |
PF-05280014
n=353 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 8 Day 1
|
65.55 mcg/mL
Interval 0.69 to 155.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 1 Day 1
|
0.00 mcg/mL
Interval 0.0 to 98.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 1 Day 8
|
29.80 mcg/mL
Interval 0.0 to 101.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 3 Day 1
|
50.40 mcg/mL
Interval 1.74 to 171.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 4 Day 1
|
54.35 mcg/mL
Interval 0.0 to 148.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 5 Day 1
|
60.00 mcg/mL
Interval 0.0 to 244.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 5 Day 8
|
61.20 mcg/mL
Interval 4.64 to 150.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 7 Day 1
|
63.00 mcg/mL
Interval 1.93 to 340.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 11 Day 1
|
57.50 mcg/mL
Interval 1.52 to 251.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 14 Day 1
|
54.60 mcg/mL
Interval 0.0 to 187.0
|
—
|
|
Serum Trough (Pre-dose) Concentration of Trastuzumab-EU at Selected Cycles: PK Population
Cycle 17 Day 1
|
45.10 mcg/mL
Interval 45.1 to 45.1
|
—
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 3, 5, 8, 11, 14, 17Population: Safety population was used for analysis, included all participants who received at least 1 dose of study drug. Here "n" signifies participants evaluable at specified time points only.
Two sensitive, specific, and semi-quantitative electrochemiluminescent (ECL) immunoassays, 1 for detecting antibodies against PF-05280014 and the other for detecting antibodies against trastuzumab, were used to analyze ADA samples. Serum samples were first screened for ADA. Any samples that were positive in the screening assay were further analyzed to confirm the positive result and determine the antibody titers. All samples were taken prior to dosing. The number of participants with a positive sample (titer \>=1.0) is provided.
Outcome measures
| Measure |
PF-05280014
n=349 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=353 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 1 Day 1 (prior to treatment)
|
30 Participants
|
14 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 3 Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 5 Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 8 Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 11 Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 14 Day 1
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Sample: Safety Population
Cycle 17 Day 1
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (prior to treatment)Population: Safety population was used for analysis, included all participants who received at least 1 dose of study drug.
Human serum samples testing positive for the presence of ADA (anti-PF-05280014 or anti-trastuzumab-EU) were analyzed for the presence or absence of NAb (neutralizing anti-PF-05280014 or neutralizing anti-trastuzumab-EU antibodies) following a tiered approach using screening and titer determination. The number of participants at baseline (prior to treatment) with a positive NAb sample (titer \>=1.48) is provided.
Outcome measures
| Measure |
PF-05280014
n=349 Participants
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=350 Participants
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Number of Participants With Positive Neutralizing Antibodies (Nab) Prior to Treatment: Safety Population
|
20 Participants
|
9 Participants
|
Adverse Events
PF-05280014
Serious events: 67 serious events
Other events: 337 other events
Deaths: 61 deaths
Trastuzumab-EU
Serious events: 69 serious events
Other events: 334 other events
Deaths: 67 deaths
Serious adverse events
| Measure |
PF-05280014
n=349 participants at risk
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=353 participants at risk
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.86%
3/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.86%
3/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
1.1%
4/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Cardiovascular insufficiency
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Eye disorders
Macular degeneration
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Proctalgia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Cyst rupture
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Death
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Disease progression
|
4.3%
15/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
4.5%
16/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
1.1%
4/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cellulitis
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
1.1%
4/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Mastitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Peritonitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.7%
6/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.85%
3/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.86%
3/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Wound infection
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
4/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian germ cell teratoma benign
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Ischaemic stroke
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.85%
3/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.86%
3/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Suicide attempt
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
5/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.57%
2/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Endocrine disorders
Thyroiditis subacute
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Ileus
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pain
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Infected skin ulcer
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial adenocarcinoma
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasopharyngeal neoplasm benign
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.57%
2/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebral venous sinus thrombosis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.28%
1/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypersensitivity pneumonitis
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.29%
1/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
0.00%
0/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
PF-05280014
n=349 participants at risk
Participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received PF-05280014 on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as intravenous (IV) infusions until the end of the study. The first infusion of PF-05280014 was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of PF-05280014 were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
Trastuzumab-EU
n=353 participants at risk
Participants with HER2-positive breast cancer received trastuzumab-EU on Days 1, 8, 15 and 22 of each 28-day cycle followed by paclitaxel on Days 1, 8 and 15 of each 28-day cycle both as IV infusions until the end of the study. The first infusion of trastuzumab-EU was 4 mg/kg over 90 minutes on Cycle 1 Day 1. Subsequent weekly infusions of trastuzumab-EU were 2 mg/kg over 30 to 90 minutes. Paclitaxel was administered at a dose of 80 mg/m\^2 over 60 minutes. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the trastuzuamab-EU could be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
35.0%
122/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
38.0%
134/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
10.3%
36/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
12.7%
45/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
27.8%
97/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
26.6%
94/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
14/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.1%
32/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
6.9%
24/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
8.8%
31/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
61/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
18.4%
65/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
16.6%
58/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
19.8%
70/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
6.6%
23/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
3.7%
13/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
28/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
7.4%
26/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Asthenia
|
15.2%
53/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
13.0%
46/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Fatigue
|
13.2%
46/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
14.4%
51/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Oedema peripheral
|
7.7%
27/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
12.7%
45/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Pyrexia
|
11.7%
41/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
8.2%
29/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Respiratory tract infection viral
|
6.6%
23/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
3.7%
13/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.3%
36/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
13.0%
46/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
9.5%
33/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
8.8%
31/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
42/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
12.7%
45/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.3%
36/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
8.8%
31/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
8.0%
28/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
7.4%
26/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Ejection fraction decreased
|
14.0%
49/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
12.7%
45/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Investigations
Weight increased
|
5.7%
20/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
6.2%
22/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.6%
23/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
5.9%
21/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.6%
44/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
10.8%
38/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.2%
18/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.3%
33/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.7%
20/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
4.0%
14/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.4%
26/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.9%
35/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.3%
22/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
6.8%
24/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Dizziness
|
10.9%
38/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
8.5%
30/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Headache
|
15.2%
53/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
20.7%
73/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
9.5%
33/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.6%
34/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
26.6%
93/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
24.1%
85/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
33/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.1%
32/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.7%
20/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
6.2%
22/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
15/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
6.5%
23/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
54.2%
189/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
52.7%
186/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.4%
12/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
6.5%
23/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.4%
26/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
7.4%
26/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Vascular disorders
Hypertension
|
11.5%
40/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
9.3%
33/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.2%
18/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
3.4%
12/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.6%
16/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
5.1%
18/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
General disorders
Chills
|
4.9%
17/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
5.1%
18/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
6.0%
21/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
5.4%
19/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
1.4%
5/349 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
5.4%
19/353 • Adverse events (AEs) and serious AEs (SAEs) which occurred from the time the participant had taken at least 1 dose of study drug and the time of informed consent, respectively, through 70 days after the last dose of study drug (maximum up to 328 weeks)
All-cause mortality: The total number of deaths occurred during study are reported for all randomized participants, not only for treated participants, and included deaths which occurred beyond 70 days post last study drug dose (i.e. beyond 328 weeks). SAEs and other AEs: Analysis performed on safety population. The safety population included all participants who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER