Trial Outcomes & Findings for Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) (NCT NCT02105636)
NCT ID: NCT02105636
Last Updated: 2022-10-05
Results Overview
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
361 participants
Primary outcome timeframe
From date of randomization to date of death (Up to approximately 18 months)
Results posted on
2022-10-05
Participant Flow
Participant milestones
| Measure |
Nivolumab 3mg/kg
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Pre-Treatment
STARTED
|
240
|
121
|
|
Pre-Treatment
COMPLETED
|
236
|
111
|
|
Pre-Treatment
NOT COMPLETED
|
4
|
10
|
|
Treatment
STARTED
|
236
|
111
|
|
Treatment
COMPLETED
|
1
|
0
|
|
Treatment
NOT COMPLETED
|
235
|
111
|
Reasons for withdrawal
| Measure |
Nivolumab 3mg/kg
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Pre-Treatment
Disease Progression
|
1
|
0
|
|
Pre-Treatment
Participant request to discontinue study treatment
|
1
|
2
|
|
Pre-Treatment
Participant withdrew consent
|
0
|
6
|
|
Pre-Treatment
Participant no longer meets study criteria
|
2
|
2
|
|
Treatment
Study Drug Toxicity
|
14
|
10
|
|
Treatment
Adverse event unrelated to study drug
|
19
|
3
|
|
Treatment
Participant request to discontinue study treatment
|
8
|
6
|
|
Treatment
Participant withdrew consent
|
5
|
1
|
|
Treatment
Lost to Follow-up
|
1
|
0
|
|
Treatment
Maximum Clinical Benefit
|
1
|
3
|
|
Treatment
Poor/Non-compliance
|
0
|
1
|
|
Treatment
Participant no longer meets study criteria
|
1
|
0
|
|
Treatment
Other reasons
|
1
|
0
|
|
Treatment
Disease Progression
|
185
|
87
|
Baseline Characteristics
Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
Baseline characteristics by cohort
| Measure |
Nivolumab 3mg/kg
n=240 Participants
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
n=121 Participants
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
Total
n=361 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 years
STANDARD_DEVIATION 10.15 • n=99 Participants
|
59.4 years
STANDARD_DEVIATION 11.00 • n=107 Participants
|
59.1 years
STANDARD_DEVIATION 10.43 • n=206 Participants
|
|
Age, Customized
< 65 years
|
172 Participants
n=99 Participants
|
76 Participants
n=107 Participants
|
248 Participants
n=206 Participants
|
|
Age, Customized
>=65 and <75 years
|
56 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
95 Participants
n=206 Participants
|
|
Age, Customized
>=75 years
|
12 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
43 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
61 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=99 Participants
|
103 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
196 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
29 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic/Latino
|
132 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
192 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
99 Participants
n=99 Participants
|
57 Participants
n=107 Participants
|
156 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to date of death (Up to approximately 18 months)Population: All randomized participants
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=240 Participants
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
n=121 Participants
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Overall Survival (OS)
|
7.49 Months
Interval 5.49 to 9.1
|
5.06 Months
Interval 4.04 to 6.05
|
SECONDARY outcome
Timeframe: From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)Population: All randomized participants
PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who: * Die without a reported progression were considered to have progressed on the date of their death. * Did not progress or die were censored on the date of their last evaluable tumor assessment. * Without any on study tumor assessments and did not die were censored on their date of randomization. * Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=240 Participants
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
n=121 Participants
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Investigator-Assessed Progression-Free Survival (PFS)
|
2.04 Months
Interval 1.91 to 2.14
|
2.33 Months
Interval 1.94 to 3.06
|
SECONDARY outcome
Timeframe: From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)Population: All randomized participants
ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=240 Participants
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
n=121 Participants
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Investigator-Assessed Objective Response Rate (ORR)
|
13.3 Percentage of Participants
Interval 9.3 to 18.3
|
5.8 Percentage of Participants
Interval 2.4 to 11.6
|
POST_HOC outcome
Timeframe: From date of randomization to date of death (Up to approximately 87 months)Population: All randomized participants
OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method. Note: This outcome measure represents an updated version of the primary endpoint to include additional data collection that has occurred after the primary completion date. (Assessments were made until 10-Sep-2021)
Outcome measures
| Measure |
Nivolumab 3mg/kg
n=240 Participants
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
|
Investigators Choice
n=121 Participants
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Overall Survival (OS) - Extended Collection
|
7.72 Months
Interval 5.68 to 8.74
|
5.06 Months
Interval 4.04 to 6.24
|
Adverse Events
Nivolumab 3mg/kg
Serious events: 165 serious events
Other events: 210 other events
Deaths: 220 deaths
Investigator Choice
Serious events: 87 serious events
Other events: 108 other events
Deaths: 119 deaths
Serious adverse events
| Measure |
Nivolumab 3mg/kg
n=236 participants at risk
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression
|
Investigator Choice
n=111 participants at risk
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Acute myocardial infarction
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrial flutter
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Atrioventricular block complete
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiac failure
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Cardiovascular disorder
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Pericarditis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypophysitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Secondary hypothyroidism
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Blindness unilateral
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Abdominal pain
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric disorder
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Parotid gland haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Tongue haemorrhage
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Catheter site pain
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Chills
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Death
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Face oedema
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
General physical health deterioration
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Localised oedema
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Malaise
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
2.1%
5/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Ulcer haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Immune system disorders
Eosinophilic granulomatosis with polyangiitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Cellulitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Clostridium difficile colitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Device related infection
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Infection
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Localised infection
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lower respiratory tract infection
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Lymphangitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Neutropenic sepsis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Osteomyelitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Otitis media
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Peritonitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
7.2%
17/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
5/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia bacterial
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia pseudomonal
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Purulent discharge
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
2.1%
5/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sepsis
|
2.5%
6/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Septic shock
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Sinusitis
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Skin infection
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Systemic infection
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Tracheitis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Urinary tract infection
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Wound infection
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Shunt thrombosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Tracheostomy malfunction
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Vascular pseudoaneurysm ruptured
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Injury, poisoning and procedural complications
Wound haemorrhage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood bilirubin increased
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
General physical condition abnormal
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Liver function test abnormal
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Liver function test increased
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Platelet count decreased
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Transaminases increased
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Dehydration
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperamylasaemia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Malnutrition
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Head and neck cancer
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
39.8%
94/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
49.5%
55/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Cerebrovascular accident
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Encephalopathy
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Focal dyscognitive seizures
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Hydrocephalus
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Ischaemic stroke
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Speech disorder
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Syncope
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Product Issues
Device leakage
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Product Issues
Device occlusion
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Agoraphobia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Confusional state
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Delirium
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.7%
11/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal stenosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
4.2%
10/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.1%
5/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dermatomyositis
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Deep vein thrombosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haematoma
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Haemorrhage
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertensive urgency
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypotension
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypovolaemic shock
|
0.00%
0/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Shock haemorrhagic
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Superior vena cava syndrome
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Venous thrombosis
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Other adverse events
| Measure |
Nivolumab 3mg/kg
n=236 participants at risk
Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression
|
Investigator Choice
n=111 participants at risk
Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.5%
53/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
37.8%
42/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.85%
2/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
9/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Cardiac disorders
Tachycardia
|
3.0%
7/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
7/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Endocrine disorders
Hypothyroidism
|
8.9%
21/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
7/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Eye disorders
Lacrimation increased
|
0.42%
1/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Constipation
|
18.2%
43/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.9%
21/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
19.9%
47/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
24.3%
27/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
8/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dyspepsia
|
3.0%
7/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Dysphagia
|
12.7%
30/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
15.3%
17/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Nausea
|
23.3%
55/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
37/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Stomatitis
|
5.9%
14/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
12/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Gastrointestinal disorders
Vomiting
|
11.9%
28/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.4%
16/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Asthenia
|
11.4%
27/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
21.6%
24/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Face oedema
|
4.7%
11/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Fatigue
|
28.4%
67/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
33.3%
37/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Mucosal inflammation
|
4.7%
11/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.1%
19/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Oedema peripheral
|
8.1%
19/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
5/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
General disorders
Pyrexia
|
15.7%
37/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.4%
16/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Oral candidiasis
|
4.7%
11/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Pneumonia
|
6.8%
16/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
4.5%
5/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Infections and infestations
Respiratory tract infection
|
2.5%
6/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Alanine aminotransferase increased
|
3.8%
9/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
14/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Blood alkaline phosphatase increased
|
7.6%
18/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lipase increased
|
5.5%
13/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Lymphocyte count decreased
|
3.4%
8/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
Weight decreased
|
14.8%
35/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
17.1%
19/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Investigations
White blood cell count decreased
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Decreased appetite
|
19.5%
46/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
18.9%
21/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.2%
17/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
16/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
9/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
5.1%
12/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.7%
11/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
7/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.6%
25/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
13.5%
15/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.1%
19/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.2%
17/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.00%
0/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.2%
17/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
9/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
5.5%
13/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
7.2%
8/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Dizziness
|
3.8%
9/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
7/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Headache
|
9.7%
23/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Neuropathy peripheral
|
2.5%
6/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
9/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Nervous system disorders
Paraesthesia
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Anxiety
|
3.8%
9/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
8.1%
9/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Depression
|
5.1%
12/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
2.7%
3/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Psychiatric disorders
Insomnia
|
5.5%
13/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
6.3%
7/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.7%
37/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
11.7%
13/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
13.6%
32/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
12/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.1%
5/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
9.9%
11/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
5/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
5.9%
14/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
1.8%
2/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.7%
4/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
14.4%
16/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.9%
14/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
10.8%
12/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.3%
3/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.7%
23/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
0.90%
1/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.3%
22/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
5.4%
6/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
|
Vascular disorders
Hypertension
|
6.8%
16/236 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
3.6%
4/111 • Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER