Trial Outcomes & Findings for A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer (NCT NCT04100018)
NCT ID: NCT04100018
Last Updated: 2025-06-12
Results Overview
rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1030 participants
Primary outcome timeframe
from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)
Results posted on
2025-06-12
Participant Flow
Participant milestones
| Measure |
Nivolumab + Docetaxel + Prednisone
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Pre-Treatment Period
STARTED
|
514
|
516
|
|
Pre-Treatment Period
COMPLETED
|
510
|
510
|
|
Pre-Treatment Period
NOT COMPLETED
|
4
|
6
|
|
Treatment Period
STARTED
|
510
|
510
|
|
Treatment Period
COMPLETED
|
19
|
11
|
|
Treatment Period
NOT COMPLETED
|
491
|
499
|
Reasons for withdrawal
| Measure |
Nivolumab + Docetaxel + Prednisone
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Pre-Treatment Period
Not Reported
|
0
|
4
|
|
Pre-Treatment Period
Subject no longer meets study criteria
|
1
|
1
|
|
Pre-Treatment Period
Poor/Non-compliance
|
1
|
0
|
|
Pre-Treatment Period
Participant withdrew consent
|
2
|
0
|
|
Pre-Treatment Period
Participant request to discontinue study treatment
|
0
|
1
|
|
Treatment Period
Ongoing Treatment
|
1
|
0
|
|
Treatment Period
Other Reason
|
26
|
37
|
|
Treatment Period
Completed treatment as per protocol
|
1
|
2
|
|
Treatment Period
Maximum clinical benefit
|
3
|
0
|
|
Treatment Period
Adverse event unrelated to study drug
|
13
|
12
|
|
Treatment Period
Study drug toxicity
|
67
|
28
|
|
Treatment Period
Disease Progression
|
284
|
327
|
|
Treatment Period
Administrative reasons by sponsor
|
16
|
30
|
|
Treatment Period
Poor/Non-Compliance
|
1
|
0
|
|
Treatment Period
Lost to Follow-up
|
2
|
2
|
|
Treatment Period
Death
|
16
|
11
|
|
Treatment Period
Participant withdrew consent
|
10
|
10
|
|
Treatment Period
Participant request to discontinue study treatment
|
33
|
32
|
|
Treatment Period
Adverse Event
|
14
|
6
|
|
Treatment Period
Lack of Efficacy
|
4
|
2
|
Baseline Characteristics
A Study of Nivolumab or Placebo in Combination With Docetaxel in Men With Advanced Castration-resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Nivolumab + Docetaxel + Prednisone
n=514 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=516 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Total
n=1030 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
69.6 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
514 Participants
n=5 Participants
|
515 Participants
n=7 Participants
|
1029 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
333 participants
n=5 Participants
|
329 participants
n=7 Participants
|
662 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
20 participants
n=5 Participants
|
15 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
35 participants
n=5 Participants
|
45 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other pacific islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
40 participants
n=5 Participants
|
38 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Japanese
|
33 participants
n=5 Participants
|
45 participants
n=7 Participants
|
78 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian other
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
30 participants
n=5 Participants
|
27 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
19 participants
n=5 Participants
|
16 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian Indian
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from randomization to the first date of documented progression or death due to any cause, whichever occurs first (up to approximately 31 months)Population: All randomized participants
rPFS for randomized participants is the time between randomization and the first date of documented progression or death due to any cause, whichever occurs first. The rPFS was censored at the last radiographic tumor assessment up to the start of subsequent cancer therapy for those without progression or death. It was also censored at the date of last radiographic tumor assessment prior to the missed tumor assessments for participants who had progressive disease (PD) or death immediately after more than one consecutive missed tumor assessments. Radiographic progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=514 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=516 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Radiographic Progressive Free Survival (rPFS) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group 3 (PCWG3)
|
9.43 months
Interval 8.48 to 10.32
|
8.74 months
Interval 8.38 to 9.99
|
PRIMARY outcome
Timeframe: From randomization to the date of death from any cause (Up to approximately 31 months)Population: All randomized participants
OS for all randomized participants is the time between randomization and the date of death from any cause. For participants who are alive, their survival time was censored at the last date that they were known to be alive. OS was censored for participants at the date of randomization if they had no follow-up.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=514 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=516 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Overall Survival (OS)
|
18.73 months
Interval 16.95 to 21.03
|
18.92 months
Interval 17.31 to 22.01
|
SECONDARY outcome
Timeframe: From date of randomization to the date of objectively documented progression per PCWG3 or the date of subsequent systemic cancer therapy, whichever occurs first (Up to approximately 52 months)Population: All response evaluable participants
Objective Response Rate per PCWG3 (ORR-PCWG3) is the percentage of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=216 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=204 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
|
27.3 percentage of participants
Interval 21.5 to 33.8
|
23.5 percentage of participants
Interval 17.9 to 30.0
|
SECONDARY outcome
Timeframe: From randomization to the date of the first documented CR or PR (Up to approximately 52 months)Population: All Confirmed Responders (PR + CR)
Time to Response per PCWG3 (TTR-PCWG3) is the time from randomization to the date of the first documented CR or PR per PCWG3, as determined by BICR. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=59 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=48 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Time to Response (TTR) Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
|
2.17 months
Interval 1.4 to 7.8
|
2.20 months
Interval 1.7 to 8.2
|
SECONDARY outcome
Timeframe: From randomization date to the date of first documented radiographic progression or death due to any cause whichever occurs first (Up to approximately 52 months)Population: All Confirmed Responders (PR + CR)
Duration of Response per PCWG3 (DOR-PCWG3) is time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3,as determined by BICR, or death due to any cause whichever occurs first. Complete Response (CR) is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR) is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Radiographic progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). The appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=59 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=48 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Duration of Response Assessed by Blinded Independent Central Review (BICR) Per Prostate Cancer Working Group (PCWG3)
|
8.31 months
Interval 6.18 to 10.15
|
8.11 months
Interval 6.34 to 8.74
|
SECONDARY outcome
Timeframe: Up to approximately 52 monthsPopulation: All randomized participants with baseline and at least one post-baseline PSA assessments
PSA Response Rate (PSA-RR) is the percentage of randomized participants with a 50% or greater decrease in PSA from baseline to the lowest post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=498 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=503 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Prostate-specific Antigen (PSA) Response Rate (PSA-RR)
|
42.4 percentage of participants
Interval 38.0 to 46.8
|
41.6 percentage of participants
Interval 37.2 to 46.0
|
SECONDARY outcome
Timeframe: from randomization to the date of PSA Progression (Up to approximately 31 months)Population: All randomized participants
Time to PSA Progression (TTP-PSA) is the time between randomization to the date of PSA progression per PCWG3 in randomized participants. PSA Progression: For participants with an initial PSA decline from baseline, the date of PSA progression is the date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from the nadir are documented and confirmed by a second consecutive PSA value at least 3 weeks later. For participants with no PSA decline from baseline, the date of PSA progression is date that an increase of 25% or more and an absolute increase of 2 ng/mL or more from baseline are documented at or beyond Week 13. Baseline was defined as valuations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations. Censored at date of last PSA evaluation on/prior to start of subsequent cancer therapy.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=514 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=516 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Time to PSA Progression (TTP-PSA)
|
6.28 months
Interval 5.82 to 6.97
|
6.21 months
Interval 5.65 to 6.77
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Adverse Events
|
501 Participants
|
503 Participants
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)Population: All treated participants
Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death or Is life-threatening or requires inpatient hospitalization or causes prolongation of existing hospitalization or results in persistent or significant disability/incapacity or is a congenital anomaly/birth defect.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Serious Adverse Events
|
223 Participants
|
192 Participants
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Adverse Events Leading to Discontinuation
|
148 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)Population: All treated participants
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Adrenal insufficiency
|
7 Participants
|
4 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Hypothyroidism
|
27 Participants
|
11 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Thyroiditis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Diabetes mellitus
|
1 Participants
|
2 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Diabetic ketoacidosis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Type 1 diabetes mellitus
|
1 Participants
|
0 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Hyperthyroidism
|
20 Participants
|
11 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Immune-mediated hypophysitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Endocrine Immune-Mediated Adverse Events
Hypopituitarism
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose and 100 days after last dose of study therapy (Up to approximately 13 months)Population: All treated participants
Immune-mediated adverse events are AEs consistent with an immune-mediated mechanism or immune-mediated component for which non-inflammatory etiologies (eg, infection or tumor progression) have been ruled out. IMAEs can include events with an alternate etiology which were exacerbated by the induction of autoimmunity. An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Colitis
|
4 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Pneumonitis
|
15 Participants
|
2 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Interstitial lung disease
|
5 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Immune-mediated lung disease
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Diarrhoea
|
8 Participants
|
2 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Enterocolitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Alanine aminotransferase increased
|
5 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Aspartate aminotransferase increased
|
3 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Hypertransaminasaemia
|
3 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Autoimmune hepatitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Immune-mediated hepatitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Blood bilirubin increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Cholangitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Blood creatinine increased
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Acute kidney injury
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Immune-mediated nephritis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Rash
|
14 Participants
|
7 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Rash maculo-papular
|
3 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Rash pustular
|
2 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Dermatitis
|
1 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Dermatitis acneiform
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Drug eruption
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Pemphigoid
|
1 Participants
|
0 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Erythema multiforme
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Immune-mediated dermatitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Rash macular
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Infusion related reaction
|
3 Participants
|
3 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Hypersensitivity
|
0 Participants
|
1 Participants
|
|
Number of Participants With Non-Endocrine Immune-Mediated Adverse Events
Infusion related hypersensitivity reaction
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)Population: All treated participants
An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Select Adverse Events
Diarrhoea
|
176 Participants
|
159 Participants
|
|
Number of Participants With Select Adverse Events
Colitis
|
7 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Enterocolitis
|
2 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Frequent bowel movements
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Alanine aminotransferase increased
|
36 Participants
|
14 Participants
|
|
Number of Participants With Select Adverse Events
Aspartate aminotransferase increased
|
26 Participants
|
15 Participants
|
|
Number of Participants With Select Adverse Events
Blood alkaline phosphatase increased
|
23 Participants
|
22 Participants
|
|
Number of Participants With Select Adverse Events
Blood bilirubin increased
|
8 Participants
|
4 Participants
|
|
Number of Participants With Select Adverse Events
Gamma-glutamyltransferase increased
|
5 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events
Hepatic cytolysis
|
4 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Transaminases increased
|
4 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Autoimmune hepatitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Cholangitis
|
2 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Hyperbilirubinaemia
|
2 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Hypertransaminasaemia
|
2 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Hepatic enzyme increased
|
1 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Hepatitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Immune-mediated hepatitis
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Liver injury
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Liver disorder
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Pneumonitis
|
26 Participants
|
6 Participants
|
|
Number of Participants With Select Adverse Events
Interstitial lung disease
|
7 Participants
|
4 Participants
|
|
Number of Participants With Select Adverse Events
Acute respiratory failure
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Immune-mediated lung disease
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Lung infiltration
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Idiopathic interstitial pneumonia
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Blood creatinine increased
|
22 Participants
|
7 Participants
|
|
Number of Participants With Select Adverse Events
Acute kidney injury
|
7 Participants
|
9 Participants
|
|
Number of Participants With Select Adverse Events
Renal failure
|
3 Participants
|
5 Participants
|
|
Number of Participants With Select Adverse Events
Blood urea increased
|
2 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Immune-mediated nephritis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Rash
|
51 Participants
|
34 Participants
|
|
Number of Participants With Select Adverse Events
Pruritus
|
47 Participants
|
20 Participants
|
|
Number of Participants With Select Adverse Events
Eczema
|
10 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events
Rash maculo-papular
|
11 Participants
|
6 Participants
|
|
Number of Participants With Select Adverse Events
Dermatitis
|
6 Participants
|
4 Participants
|
|
Number of Participants With Select Adverse Events
Palmar-plantar erythrodysaesthesia syndrome
|
5 Participants
|
22 Participants
|
|
Number of Participants With Select Adverse Events
Urticaria
|
5 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events
Erythema
|
4 Participants
|
11 Participants
|
|
Number of Participants With Select Adverse Events
Psoriasis
|
4 Participants
|
3 Participants
|
|
Number of Participants With Select Adverse Events
Skin exfoliation
|
4 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Dermatitis acneiform
|
3 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Rash macular
|
3 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Dermatitis allergic
|
2 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Rash erythematous
|
2 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Rash pustular
|
3 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Vitiligo
|
2 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Blister
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Dermatitis atopic
|
1 Participants
|
2 Participants
|
|
Number of Participants With Select Adverse Events
Dermatitis exfoliative
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Drug eruption
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Erythema multiforme
|
1 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Exfoliative rash
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Pemphigoid
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Photosensitivity reaction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Rash papular
|
1 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Rash pruritic
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Immune-mediated dermatitis
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Infusion related reaction
|
22 Participants
|
27 Participants
|
|
Number of Participants With Select Adverse Events
Hypersensitivity
|
6 Participants
|
4 Participants
|
|
Number of Participants With Select Adverse Events
Anaphylactic reaction
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Anaphylactic shock
|
1 Participants
|
0 Participants
|
|
Number of Participants With Select Adverse Events
Bronchospasm
|
0 Participants
|
1 Participants
|
|
Number of Participants With Select Adverse Events
Infusion related hypersensitivity reaction
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 52 monthsPopulation: All treated participants
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants Who Died
|
258 Participants
|
227 Participants
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 25 months)Population: All treated participants
The severity of laboratory test results were graded based upon the participants symptoms according to the Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0); Hematology parameters were evaluated for severity according to the following scale: Grade 0 is defined as absence of an AE or within normal limits; Grade 1 = Mild - transient or mild discomfort; no medical intervention required; Grade 2 = Moderate - mild to moderate limitation in activity; Grade 3 = Severe; Grade 4 = Life threatening. Number of participants with worst grade change results to Grade 3 or Grade 4 laboratory test results is presented. E.g., the row title HEMOGLOBIN Grade 0 to Grade 3, Grade 0 is baseline and Grade 3 is post baseline.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 3 to Grade 4
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 0 to Grade 3
|
2 Participants
|
3 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 0 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 1 to Grade 3
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 1 to Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
PLATELET COUNT Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 0 to Grade 3
|
30 Participants
|
28 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 0 to Grade 4
|
11 Participants
|
13 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 1 to Grade 3
|
5 Participants
|
3 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 1 to Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 2 to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LEUKOCYTES Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 0 to Grade 3
|
22 Participants
|
17 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 0 to Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 1 to Grade 3
|
24 Participants
|
22 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 1 to Grade 4
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 2 to Grade 3
|
19 Participants
|
30 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 2 to Grade 4
|
2 Participants
|
2 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 3 to Grade 3
|
10 Participants
|
19 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 3 to Grade 4
|
2 Participants
|
4 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
LYMPHOCYTES Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 0 to Grade 3
|
18 Participants
|
16 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 0 to Grade 4
|
44 Participants
|
39 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 1 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 2 to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 2 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ANC Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 0 to Grade 3
|
5 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 1 to Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALP Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 0 to Grade 3
|
6 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 1 to Grade 3
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 1 to Grade 4
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
AMT Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 0 to Grade 3
|
7 Participants
|
2 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 0 to Grade 4
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
ALT Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 0 to Grade 3
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
BILIRUBIN Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 0 to Grade 3
|
4 Participants
|
4 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 1 to Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 1 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 2 to Grade 3
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 2 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
CREATININE Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 0 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERNATREMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 0 to Grade 3
|
5 Participants
|
4 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 0 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 1 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPONATREMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 0 to Grade 3
|
8 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 0 to Grade 4
|
2 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 1 to Grade 3
|
2 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 1 to Grade 4
|
0 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 2 to Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERKALEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 0 to Grade 3
|
7 Participants
|
8 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 1 to Grade 3
|
3 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOKALEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 0 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 1 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERCALCEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 0 to Grade 3
|
6 Participants
|
4 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 1 to Grade 3
|
1 Participants
|
2 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 2 to Grade 3
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 2 to Grade 4
|
3 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOCALCEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 0 to Grade 3
|
4 Participants
|
3 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 1 to Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 3 to Grade 3
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPERMAGNESEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 0 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 0 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOMAGNESEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 0 to Grade 3
|
1 Participants
|
1 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 0 to Grade 4
|
1 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 1 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 1 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 2 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 2 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 3 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 4 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HYPOGLYCEMIA Grade 4 to Grade 4
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 2 to Grade 3
|
11 Participants
|
11 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 2 to Grade 4
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 3 to Grade 3
|
0 Participants
|
0 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 0 to Grade 3
|
5 Participants
|
3 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 0 to Grade 4
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 1 to Grade 3
|
20 Participants
|
16 Participants
|
|
Number of Participants With Worst Common Terminology Criteria (CTC) Grade Laboratory Test Grade Change From Baseline
HEMOGLOBIN Grade 1 to Grade 4
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
NA Participants
Per Anemia criteria in CTC version 5.0 there is no grade 4 for hemoglobin
|
SECONDARY outcome
Timeframe: From first dose and 30 days after last dose of study therapy (Up to approximately 11 months)Population: All treated participants with at least One on-treatment thyroid stimulating hormone (TSH) measurement
Blood samples were collected for conducting specific thyroid test. Baseline is defined as evaluations or events that occur before the date and time of the first dose of study treatment. Baseline was defined as evaluations or events that occur before the date and time of the first dose of study treatment or evaluations on the same date and time of the first dose of study treatment were also considered as baseline evaluations.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=499 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=502 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > (Upper Limit of Normal) ULN
|
94 Participants
|
77 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with TSH <= Upper limit of Normal (ULN) AT Baseline
|
79 Participants
|
54 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with at Least One FT3/FT4 Test Value < LLN
|
39 Participants
|
20 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN With All Other FT3/FT4 Test Values >= LLN
|
65 Participants
|
52 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH > ULN with FT3/FT4 Test Missing
|
22 Participants
|
23 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < Lower Limit of Normal (LLN)
|
155 Participants
|
124 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with TSH >= LLN at Baseline
|
126 Participants
|
98 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with at Least One FT3/FT4 Test Value > ULN
|
33 Participants
|
14 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with all other FT3/FT4 Test Values <= ULN
|
116 Participants
|
106 Participants
|
|
Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests
TSH < LLN with FT3/FT4 Test Missing
|
45 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: From randomization to 1st pain symptoms at their worst over the last 24 hours (Up to approximately 31 monthsPopulation: All randomized participants
The BPI-SF is an instrument to assess pain and includes severity and interference scores. BPI-SF is an 11-item self-report questionnaire designed to assess severity and impact of pain on daily function. Participants rate severity of pain at its "worst," "least," and "average" in last 24 hours using an 11-point numerical rating scale with anchors of "no pain" and "pain as bad. The participant's assessment of pain with BPI-SF Item number 3 (pain symptoms at their worst over the last 24 hours) form basis for analysis. Time to pain progression is time between date of randomization and date of first increase in worst pain intensity. Pain progression occurred if an increase in worst pain intensity of \>= 2 points is observed from baseline and maintained over 2 consecutive time periods. Baseline was evaluations or events that occur before date and time of first dose of study treatment or evaluations on same date and time of first dose of study treatment were also considered as baseline.
Outcome measures
| Measure |
Nivolumab + Docetaxel + Prednisone
n=514 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=516 Participants
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Time to Pain Progression as Assessed by Brief Pain Inventory-Short Form (BPI-SF)
|
11.53 months
Interval 10.28 to 13.57
|
12.42 months
Interval 11.07 to 13.63
|
Adverse Events
Nivolumab + Docetaxel + Prednisone
Serious events: 256 serious events
Other events: 479 other events
Deaths: 259 deaths
Placebo + Docetaxel + Prednisone
Serious events: 242 serious events
Other events: 494 other events
Deaths: 227 deaths
Serious adverse events
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 participants at risk
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 participants at risk
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.2%
6/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.4%
12/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Blood disorder
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Bone marrow infiltration
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.3%
17/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.7%
14/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.8%
9/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.0%
10/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Arrhythmia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiogenic shock
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hyperthyroidism
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Immune-mediated hypophysitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Cataract
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anal fistula
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.4%
12/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.8%
9/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diverticulum
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dysphagia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enterocolitis
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal inflammation
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrointestinal necrosis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Leukoplakia oral
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophagitis haemorrhagic
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Peptic ulcer haemorrhage
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest discomfort
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chest pain
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Death
|
1.8%
9/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Disease progression
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.6%
8/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Performance status decreased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
1.4%
7/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Sudden death
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Acute cholecystitis necrotic
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Biliary dilatation
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Liver injury
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Anaphylactic shock
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abscess limb
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Atypical pneumonia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bone abscess
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchiolitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
2.2%
11/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.5%
13/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis streptococcal
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Coronavirus infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis intestinal perforated
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Febrile infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Intervertebral discitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella urinary tract infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Meningitis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Neutropenic sepsis
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Oral candidiasis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Osteomyelitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Perineal abscess
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
3.5%
18/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.6%
8/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia aspiration
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia bacterial
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Psoas abscess
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pulmonary sepsis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Renal abscess
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Scrotal abscess
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Scrotal infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
1.4%
7/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.0%
10/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sinusitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Spinal cord infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Streptococcal infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tuberculosis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
8/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.0%
10/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Vascular device infection
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Wound infection staphylococcal
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Chemical peritonitis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal cord injury
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood creatinine increased
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Eastern Cooperative Oncology Group performance status worsened
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
General physical condition abnormal
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Hepatitis B DNA assay positive
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Platelet count decreased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.6%
8/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated myositis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder cancer
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain cancer metastatic
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial neoplasm
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ependymoma
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
3.7%
19/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.3%
27/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary thyroid cancer
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
2.0%
10/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.5%
13/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.4%
7/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Amnesia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Basal ganglia stroke
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Central nervous system lesion
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Hemiparesis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Ischaemic stroke
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Loss of consciousness
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Malignant spinal cord compression
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuralgia
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Presyncope
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Spinal cord compression
|
1.2%
6/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.2%
6/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Superior sagittal sinus thrombosis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device dislocation
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device occlusion
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Needle issue
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Adjustment disorder with anxiety
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Calculus bladder
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Calculus urethral
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Dysuria
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
2.5%
13/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal colic
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urethral obstruction
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.78%
4/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract inflammation
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.98%
5/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
13/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.39%
2/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
6/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
1.6%
8/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pemphigoid
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Aortic dissection
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.59%
3/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Haematoma
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypovolaemic shock
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Venous thrombosis limb
|
0.20%
1/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nivolumab + Docetaxel + Prednisone
n=510 participants at risk
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 milligram per meter square (mg/m\^2) intravenous (IV) once in a week (Q3W) + Prednisone 5 milligram (mg) orally (PO) twice a day (BID) + Nivolumab 360 mg IV Q3W for maximum 10 cycles, followed by Nivolumab 480 mg IV once in four weeks (Q4W) until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
Placebo + Docetaxel + Prednisone
n=510 participants at risk
Participants with metastatic castration resistant prostate cancer (mCRPC) who are chemotherapy-naïve for mCRPC and have received at least 1 but no more than 2 second-generation hormonal manipulations received Docetaxel 75 mg/m\^2 IV Q3W + Prednisone 5 mg PO BID + Placebo IV Q3W for maximum 10 cycles, followed by Placebo IV Q4W until disease progression or unacceptable toxicity or maximum of 2 years from the date of first dose or withdraw of consent.
|
|---|---|---|
|
Nervous system disorders
Neuropathy peripheral
|
14.9%
76/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
14.7%
75/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia
|
30.8%
157/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
32.4%
165/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.8%
40/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
11.4%
58/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Endocrine disorders
Hypothyroidism
|
5.7%
29/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
2.7%
14/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Eye disorders
Lacrimation increased
|
3.1%
16/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.5%
28/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
22.0%
112/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
19.8%
101/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
34.3%
175/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
31.8%
162/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
21.2%
108/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
26.3%
134/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
6.7%
34/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.9%
20/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
60/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
11.6%
59/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
22.2%
113/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
21.2%
108/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
27.6%
141/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
29.2%
149/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Mucosal inflammation
|
3.9%
20/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.9%
30/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
17.6%
90/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
21.2%
108/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pain
|
4.7%
24/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
26/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
8.0%
41/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
10.6%
54/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
COVID-19
|
12.4%
63/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
12.2%
62/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
7.3%
37/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
6.1%
31/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.3%
22/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
26/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
7.5%
38/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.1%
16/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
27/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
3.9%
20/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
9.2%
47/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
9.0%
46/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
8.2%
42/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.2%
42/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
White blood cell count decreased
|
6.5%
33/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.6%
39/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
96/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
19.0%
97/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
34/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.4%
43/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
4.5%
23/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.7%
29/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.5%
84/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
19.0%
97/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.3%
78/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
16.7%
85/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.6%
49/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.2%
42/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.6%
39/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
10.0%
51/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.0%
41/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
10.2%
52/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
11.6%
59/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.6%
44/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
5.7%
29/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
5.1%
26/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.5%
38/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.2%
42/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
6.9%
35/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
9.2%
47/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Haematuria
|
5.7%
29/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.3%
22/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.0%
51/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
9.6%
49/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.2%
52/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.5%
38/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.7%
172/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
34.9%
178/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
7.3%
37/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
8.0%
41/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.4%
48/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
4.3%
22/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.2%
52/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
7.1%
36/510 • All cause mortality was collected from randomization till death (up to approximately 52 months), Serious adverse events and non-serious adverse events were collected from first dose till 100 days post last dose (Up to approximately 27 months).
The number at risk for All-Cause mortality represents all randomized participants. The number at risk for serious adverse events and Other (Not Including Serious) adverse events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER