Trial Outcomes & Findings for A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks (NCT NCT02713867)
NCT ID: NCT02713867
Last Updated: 2023-02-14
Results Overview
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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 mm. Note: the appearance of one or more new lesions is also considered progression.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
363 participants
Primary outcome timeframe
At 6 Months
Results posted on
2023-02-14
Participant Flow
Participant milestones
| Measure |
Nivolumab 480mg
Nivolumab 480mg Q4W
|
Nivolumab 240mg
Nivolumab 240mg Q2W
|
|---|---|---|
|
Randomization
STARTED
|
180
|
183
|
|
Randomization
COMPLETED
|
178
|
180
|
|
Randomization
NOT COMPLETED
|
2
|
3
|
|
Treatment Period
STARTED
|
178
|
180
|
|
Treatment Period
COMPLETED
|
0
|
0
|
|
Treatment Period
NOT COMPLETED
|
178
|
180
|
Reasons for withdrawal
| Measure |
Nivolumab 480mg
Nivolumab 480mg Q4W
|
Nivolumab 240mg
Nivolumab 240mg Q2W
|
|---|---|---|
|
Randomization
Other Reason
|
2
|
1
|
|
Randomization
Participant Withdrew consent
|
0
|
2
|
|
Treatment Period
Other Reasons
|
22
|
28
|
|
Treatment Period
Administrative reason by sponsor
|
21
|
16
|
|
Treatment Period
No longer meets study criteria
|
2
|
1
|
|
Treatment Period
Poor/Non Compliance
|
1
|
0
|
|
Treatment Period
Maximum Clinical Benefit
|
5
|
6
|
|
Treatment Period
Withdrew consent
|
3
|
6
|
|
Treatment Period
Requested to Discontinue
|
8
|
8
|
|
Treatment Period
AE unrelated to Study Drug
|
11
|
10
|
|
Treatment Period
Death
|
7
|
3
|
|
Treatment Period
Study Drug Toxicity
|
16
|
19
|
|
Treatment Period
Disease Progression
|
82
|
83
|
Baseline Characteristics
A Dose Frequency Optimization,Trial of Nivolumab 240 mg Every 2 Weeks vs Nivolumab 480 mg Every 4 Weeks in Subjects With Advanced or Metastatic Non-small Cell Lung Cancer Who Received Up to 12 Months of Nivolumab at 3 mg/kg or 240 mg Every 2 Weeks
Baseline characteristics by cohort
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
Total
n=363 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.4 Years
STANDARD_DEVIATION 9.25 • n=5 Participants
|
66.5 Years
STANDARD_DEVIATION 8.65 • n=7 Participants
|
66.5 Years
STANDARD_DEVIATION 8.94 • n=5 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
131 Participants
n=5 Participants
|
129 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
118 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
233 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
59 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
337 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 MonthsPopulation: All Randomized Participants
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) at 6 Months
|
0.76 Proportion of Participants
Interval 0.7 to 0.83
|
0.79 Proportion of Participants
Interval 0.73 to 0.85
|
PRIMARY outcome
Timeframe: At 12 MonthsPopulation: All Randomized Participants
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) at 12 Months
|
0.53 Proportion of Participants
Interval 0.46 to 0.61
|
0.55 Proportion of Participants
Interval 0.47 to 0.62
|
SECONDARY outcome
Timeframe: At 24 MonthsPopulation: All Randomized Participants
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) at 24 Months
|
0.34 Proportion of Participants
Interval 0.27 to 0.42
|
0.35 Proportion of Participants
Interval 0.28 to 0.43
|
SECONDARY outcome
Timeframe: At 12 MonthsPopulation: All Randomized Participants
The proportion of participants remaining progression free and surviving at 6 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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 mm. Note: the appearance of one or more new lesions is also considered progression.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months
Squamous
|
0.50 Proportion of Participants
Interval 0.37 to 0.64
|
0.42 Proportion of Participants
Interval 0.29 to 0.55
|
|
Progression Free Survival Rate (PFSR) by Tumor Histology at 12 Months
Non Squamous
|
0.54 Proportion of Participants
Interval 0.45 to 0.63
|
0.60 Proportion of Participants
Interval 0.51 to 0.7
|
SECONDARY outcome
Timeframe: At 12 MonthsPopulation: All Randomized Participants
The proportion of participants remaining progression free and surviving at 12 months. Participants who did not progress or die will be censored on the date of their last evaluable tumor assessment. 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. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months
Complete Remission (CR)/Partial Remission (PR)
|
0.63 Proportion of Participants
Interval 0.51 to 0.75
|
0.66 Proportion of Participants
Interval 0.53 to 0.78
|
|
Progression Free Survival Rate (PFSR) by Response Criteria at 12 Months
Stable Disease (SD)
|
0.47 Proportion of Participants
Interval 0.38 to 0.57
|
0.48 Proportion of Participants
Interval 0.39 to 0.58
|
SECONDARY outcome
Timeframe: At 12 MonthsPopulation: All Randomized Participants with a response at 12 months
The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Outcome measures
| Measure |
Nivolumab 480mg
n=142 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=150 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Overall Survival (OS) Rate at 12 Months
|
0.851 Proportion of participants
Interval 0.799 to 0.902
|
0.908 Proportion of participants
Interval 0.866 to 0.951
|
SECONDARY outcome
Timeframe: From randomization to the date of death, Up to 60 MonthsPopulation: All Randomized Participants
The proportion of participants alive up to 60 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Overall Survival (OS) Rate up to 60 Months
36 Months
|
0.49 Proportion of participants
Interval 0.42 to 0.57
|
0.57 Proportion of participants
Interval 0.49 to 0.64
|
|
Overall Survival (OS) Rate up to 60 Months
12 Months
|
0.82 Proportion of participants
Interval 0.76 to 0.88
|
0.88 Proportion of participants
Interval 0.83 to 0.93
|
|
Overall Survival (OS) Rate up to 60 Months
24 Months
|
0.62 Proportion of participants
Interval 0.55 to 0.69
|
0.70 Proportion of participants
Interval 0.63 to 0.77
|
|
Overall Survival (OS) Rate up to 60 Months
48 Months
|
NA Proportion of participants
Data not calculable due to inability insufficient number of participants for analysis for K-M methodology.
|
NA Proportion of participants
Data not calculable due to inability insufficient number of participants for analysis for K-M methodology.
|
SECONDARY outcome
Timeframe: at 12 MonthsPopulation: All Randomized Participants
The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive. OS rate by histology did not have data collected after 12 months randomization.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Overall Survival Rate by Histology at 12 Months
Squamous
|
0.74 Proportion of participants
Interval 0.63 to 0.85
|
0.80 Proportion of participants
Interval 0.7 to 0.9
|
|
Overall Survival Rate by Histology at 12 Months
Non Squamous
|
0.86 Proportion of participants
Interval 0.8 to 0.92
|
0.92 Proportion of participants
Interval 0.87 to 0.97
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: All Randomized Participants
The proportion of participants alive at 12 months. OS is defined as time from the date of randomization to the date of death. Participants who did not die by the end of the study will be censored at the last known date alive. Complete Response (CR): 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): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage from the baseline study to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. OS rate by response did not have data collected after 12 months randomization.
Outcome measures
| Measure |
Nivolumab 480mg
n=180 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=183 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Overall Survival Rate by Response Criteria at 12 Months
CR/PR
|
0.90 Proportion of participants
Interval 0.82 to 0.98
|
0.93 Proportion of participants
Interval 0.87 to 1.0
|
|
Overall Survival Rate by Response Criteria at 12 Months
SD
|
0.78 Proportion of participants
Interval 0.7 to 0.86
|
0.85 Proportion of participants
Interval 0.78 to 0.92
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of participants with an Adverse Event due to any cause 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 drug and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Adverse Events (AEs)
|
91.6 Percentage of Participants
|
97.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of participants with an Serious Adverse Event due to any cause. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose: 1. results in death 2. is life-threatening (defined as an event in which the subject was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe) 3. requires inpatient hospitalization or causes prolongation of existing hospitalization 4. results in persistent or significant disability/incapacity 5. is a congenital anomaly/birth defect 6. is an important medical event (defined as a medical event(s) that may not be immediately life-threatening or result in death or hospitalization but, based upon appropriate medical and scientific judgment, may jeopardize the participant or may require intervention \[eg, medical, surgical\] to prevent one of the other serious outcomes listed in the definition above.)
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Serious Adverse Events (SAEs)
|
34.8 Percentage of Participants
|
39.4 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of Participants with an Adverse Event leading to discontinuation (AEsDC) due to any cause. 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 drug and that does not necessarily have a causal relationship with this treatment.
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Adverse Events Leading to Discontinuation (AEsDC)
|
19.1 Percentage of Participants
|
17.8 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of Participants with an Immune Mediated Adverse Events treated with Immune-Modulating Medication
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Diarrhea/Colitis
|
3.4 Percentage of Participants
|
5.0 Percentage of Participants
|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Hepatitis
|
0.0 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Pneumonitis
|
3.4 Percentage of Participants
|
3.3 Percentage of Participants
|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Nephritis and Renal Dysfunction
|
0.6 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Rash
|
7.3 Percentage of Participants
|
7.2 Percentage of Participants
|
|
Percentage of Participants With an Immune Mediated Adverse Events (IMAEs)
Hypersensitivity/Infusion Reaction
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of Participants with an Select Adverse Event due to any cause Select adverse events include adverse events in the following systems: Gastrointestinal, Hepatic, Pulmonary, Renal, Skin, Hypersensitivity/Infusion reaction and Endocrine.
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Select Adverse Events
Gastrointestinal
|
18.5 Percentage of Participants
|
25.0 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Hepatic
|
2.2 Percentage of Participants
|
10.0 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Pulmonary
|
6.7 Percentage of Participants
|
5.0 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Renal
|
10.1 Percentage of Participants
|
5.6 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Skin
|
30.9 Percentage of Participants
|
33.9 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Hypersensitivity/Infusion Reaction
|
0.0 Percentage of Participants
|
1.1 Percentage of Participants
|
|
Percentage of Participants With an Select Adverse Events
Endocrine
|
16.3 Percentage of Participants
|
18.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Other ESI included the following categories: demyelination, encephalitis, Guillain-Barré syndrome (GBS), myasthenic syndrome, pancreatitis, uveitis, myositis, myocarditis, rhabdomyolysis, and Graft Versus Host Disease (GVHD).
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants With an Event of Special Interest (ESI)
Pancreatitis
|
1.1 Percentage of Participants
|
2.8 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
demyelination
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
encephalitis
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
GBS
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
myasthenic syndrome
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
uveitis
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
myositis
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
myocarditis
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
rhabdomyolysis
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With an Event of Special Interest (ESI)
GVHD
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Percentage of Participants who experienced Death due to any cause
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Percentage of Participants Who Experienced Death
|
49.4 Percentage of Participants
|
43.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: Between first dose and 100 days after last dose of study therapy (Approximately Up to 16 months)Population: All Treated Participants
Number of participants with any laboratory test result that is clinically significant or meets the definition of an SAE (Grade 3+4 combined)
Outcome measures
| Measure |
Nivolumab 480mg
n=178 Participants
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 Participants
Nivolumab 240mg Q2W
|
|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
Alanine Aminotransferase
|
1 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Alkaline Phosphate
|
1 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Aspartate Aminotransferase
|
1 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Bilirubin, Total
|
1 Number of Participants
|
1 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Creatinine
|
1 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hemoglobin
|
0 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypercalcemia
|
2 Number of Participants
|
5 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hyperkalemia
|
4 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypermagnesemia
|
4 Number of Participants
|
5 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypernatremia
|
0 Number of Participants
|
0 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypocalcemia
|
4 Number of Participants
|
6 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypokalemia
|
3 Number of Participants
|
6 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypomagnesemia
|
3 Number of Participants
|
2 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Hypnatremia
|
6 Number of Participants
|
7 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Leukocytes
|
1 Number of Participants
|
3 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Lymphocytes
|
22 Number of Participants
|
21 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Neutrophils
|
3 Number of Participants
|
4 Number of Participants
|
|
Number of Participants With Laboratory Test Abnormalities
Platelet Count
|
3 Number of Participants
|
1 Number of Participants
|
Adverse Events
Nivolumab 480mg
Serious events: 62 serious events
Other events: 141 other events
Deaths: 88 deaths
Nivolumab 240mg
Serious events: 71 serious events
Other events: 168 other events
Deaths: 79 deaths
Serious adverse events
| Measure |
Nivolumab 480mg
n=178 participants at risk
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 participants at risk
Nivolumab 240mg Q2W
|
|---|---|---|
|
Infections and infestations
Urosepsis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Cardiac disorders
Cardiac failure
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Cardiac disorders
Myocardial infarction
|
1.1%
2/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.1%
2/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Endocrine disorders
Hypophysitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
4/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Nausea
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
2/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Asthenia
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Drowning
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Fatigue
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Pain
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Sudden death
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Appendicitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Bronchitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Cystitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Erysipelas
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Influenza
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.1%
2/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Lung abscess
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Medical device site cellulitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Pneumonia
|
3.9%
7/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Postoperative wound infection
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Pulmonary sepsis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Sepsis
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Upper respiratory tract infection bacterial
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Urinary tract infection
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Fall
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Post procedural haematuria
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.1%
2/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Wound evisceration
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
2/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue disorder
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Thoracic spinal stenosis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glottis carcinoma
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Carotid artery occlusion
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Seizure
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.1%
2/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Syncope
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Psychiatric disorders
Confusional state
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Psychiatric disorders
Depression
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Renal and urinary disorders
Subcapsular renal haematoma
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Renal and urinary disorders
Urinary retention
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Reproductive system and breast disorders
Acquired phimosis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.1%
2/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.9%
7/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
1.7%
3/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
2/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
2.2%
4/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
2.2%
4/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Vascular disorders
Aortic aneurysm
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Vascular disorders
Hypotension
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.56%
1/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Vascular disorders
Peripheral ischaemia
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
0.00%
0/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
Other adverse events
| Measure |
Nivolumab 480mg
n=178 participants at risk
Nivolumab 480mg Q4W
|
Nivolumab 240mg
n=180 participants at risk
Nivolumab 240mg Q2W
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
11/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
10.6%
19/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Endocrine disorders
Hypothyroidism
|
11.8%
21/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
9.4%
17/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
3.9%
7/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
5/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Constipation
|
10.7%
19/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
12.2%
22/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.9%
30/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
22.8%
41/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.9%
7/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.1%
11/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Nausea
|
6.7%
12/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
16.1%
29/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
12/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
11.1%
20/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Asthenia
|
13.5%
24/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
13.3%
24/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Fatigue
|
15.7%
28/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
22.2%
40/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Non-cardiac chest pain
|
2.8%
5/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Oedema peripheral
|
6.2%
11/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.3%
15/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
General disorders
Pyrexia
|
7.9%
14/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
7.8%
14/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Bronchitis
|
9.6%
17/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
12.8%
23/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Nasopharyngitis
|
6.2%
11/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.9%
16/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Pneumonia
|
4.5%
8/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Sinusitis
|
3.9%
7/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.9%
16/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Infections and infestations
Urinary tract infection
|
2.8%
5/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.1%
11/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Injury, poisoning and procedural complications
Fall
|
4.5%
8/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
2/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Amylase increased
|
2.8%
5/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Aspartate aminotransferase increased
|
0.56%
1/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Blood creatinine increased
|
7.9%
14/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
3.9%
7/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Lipase increased
|
4.5%
8/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
7.8%
14/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Investigations
Weight decreased
|
4.5%
8/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
11.1%
20/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.4%
15/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
11.1%
20/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.2%
4/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
2.2%
4/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.3%
15/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.4%
6/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.6%
10/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.1%
11/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
24/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
20.6%
37/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.5%
24/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
10.6%
19/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.7%
3/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.1%
11/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
4/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.1%
11/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
11/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.3%
15/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Dizziness
|
2.8%
5/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
9.4%
17/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Nervous system disorders
Headache
|
7.9%
14/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
8.3%
15/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Psychiatric disorders
Insomnia
|
3.4%
6/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
11.1%
20/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
3.9%
7/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.7%
12/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
23/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
20.0%
36/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
11.8%
21/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
14.4%
26/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
3.3%
6/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.4%
6/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.7%
12/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.9%
30/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
23.3%
42/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
5.0%
9/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
3.3%
6/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
|
Vascular disorders
Hypertension
|
5.6%
10/178 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
6.7%
12/180 • Adverse events and SAEs: between first dose and 100 days after last dose of study therapy (On average of 16 months up to a maximum of 56 months). All Cause Mortality, from randomization to study completion.: Approximately 5 years and 8 months.
The number at Risk for All-Cause Mortality represents all Randomized Participants to study completion. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication" or similar.
|
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
- Publication restrictions are in place
Restriction type: LTE60