Trial Outcomes & Findings for An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (NCT NCT02488759)
NCT ID: NCT02488759
Last Updated: 2023-11-13
Results Overview
Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
578 participants
Primary outcome timeframe
From first dose to 30 days post last dose (Up to 2 months)
Results posted on
2023-11-13
Participant Flow
578 participants treated
Participant milestones
| Measure |
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
113
|
195
|
133
|
8
|
6
|
123
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
116
|
|
Overall Study
NOT COMPLETED
|
113
|
195
|
133
|
8
|
6
|
7
|
Reasons for withdrawal
| Measure |
Metastatic Monotherapy
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Neoadjuvant
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
73
|
111
|
62
|
7
|
4
|
2
|
|
Overall Study
Study drug toxicity
|
11
|
33
|
31
|
0
|
0
|
2
|
|
Overall Study
Adverse event unrelated to study drug
|
9
|
11
|
7
|
0
|
1
|
0
|
|
Overall Study
Participant request to discontinue study treatment
|
6
|
8
|
4
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
3
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Maximum clinical benefit
|
3
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other reasons
|
7
|
32
|
23
|
1
|
1
|
1
|
Baseline Characteristics
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Baseline characteristics by cohort
| Measure |
Metastatic Monotherapy
n=113 Participants
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo A
n=195 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 Participants
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Neoadjuvant
n=123 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Total
n=578 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
57.4 Years
STANDARD_DEVIATION 13.5 • n=5 Participants
|
57.5 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
48.2 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
59.0 Years
STANDARD_DEVIATION 7.6 • n=4 Participants
|
66.5 Years
STANDARD_DEVIATION 15.3 • n=21 Participants
|
62.0 Years
STANDARD_DEVIATION 12.7 • n=10 Participants
|
56.4 Years
STANDARD_DEVIATION 13.8 • n=115 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
59 Participants
n=10 Participants
|
316 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
110 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
64 Participants
n=10 Participants
|
262 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
56 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
17 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
86 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
113 Participants
n=10 Participants
|
475 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 2 months)Population: All treated participants in the neoadjuvant cohort
Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort
Outcome measures
| Measure |
Neoadjuvant
n=123 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Endocrine AEs
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Gastrointestinal AEs
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Hepatic AEs
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Pulmonary AEs
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Renal AEs
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Skin AEs
|
9 Participants
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
Hypersensitivity/Infusion Reaction AEs
|
5 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose to 30 days post last dose (Up to 2 months)Population: All treated participants in the neoadjuvant cohort
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
Outcome measures
| Measure |
Neoadjuvant
n=123 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
|
6 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 29Population: All tumor reduction evaluable participants in the neoadjuvant cohort
Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed \> 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event. Participants with the following diseases will be assessed: 1. HPV positive squamous cell carcinoma of the Head and Neck (SCCHN); 2. HPV negative SCCHN; 3. Cervical Carcinoma; 4. Vaginal/Vulvar Carcinoma; 5. Merkel Cell Carcinoma
Outcome measures
| Measure |
Neoadjuvant
n=112 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Neoadjuvant: Rate of Surgery Delay
HPV positive SCCHN
|
0 Percentage of participants
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Rate of Surgery Delay
HPV negative SCCHN
|
0 Percentage of participants
Interval 0.0 to 13.7
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Rate of Surgery Delay
Cervical Carcinoma
|
7.7 Percentage of participants
Interval 0.2 to 36.0
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Rate of Surgery Delay
Vaginal/Vulvar Carcinoma
|
0 Percentage of participants
Interval 0.0 to 26.5
|
—
|
—
|
—
|
—
|
|
Neoadjuvant: Rate of Surgery Delay
Merkel Cell Carcinoma
|
2.7 Percentage of participants
Interval 0.1 to 14.2
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months)Population: All treated participants in the metastatic cohorts
Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC)
Outcome measures
| Measure |
Neoadjuvant
n=113 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
n=195 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 Participants
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
HPV positive SCCHN
|
11.5 Percentage of participants
Interval 2.4 to 30.2
|
31.0 Percentage of participants
Interval 17.6 to 47.1
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Other anogenital HPV associated cancers
|
—
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
28.6 Percentage of participants
Interval 11.3 to 52.2
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
SCCHN I-O naive
|
—
|
—
|
—
|
—
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Cervical
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
31.1 Percentage of participants
Interval 18.2 to 46.6
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Cervical first line
|
—
|
—
|
36.4 Percentage of participants
Interval 22.4 to 52.2
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Cervical second line
|
—
|
—
|
39.1 Percentage of participants
Interval 19.7 to 61.5
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Vaginal/Vulvar
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
MCC
|
64.0 Percentage of participants
Interval 42.5 to 82.0
|
58.1 Percentage of participants
Interval 42.1 to 73.0
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
NPC
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
26.2 Percentage of participants
Interval 13.9 to 42.0
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
EBV positive related gastric cancer
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)Population: All complete and partial responders in the metastatic cohorts
Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
Outcome measures
| Measure |
Neoadjuvant
n=30 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
n=72 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=50 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=1 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
EBV positive related gastric cancer
|
NA Months
Median not reached as insufficient progression events among responders
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
HPV positive SCCHN
|
44.25 Months
Interval 24.9 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
34.46 Months
Interval 10.45 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
Other anogenital HPV associated cancers
|
—
|
18.23 Months
Interval 3.68 to 27.93
|
3.71 Months
Interval 3.58 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
SCCHN I-O naive
|
—
|
—
|
—
|
—
|
NA Months
Median not reached as insufficient progression events among responders
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
Cervical, Randomized
|
NA Months
Interval 35.29 to
Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
|
NA Months
Interval 8.67 to
Median not reached as insufficient progression events among responders and Upper limit not calculable as upper CI bound does not cross 50% threshold
|
34.07 Months
Interval 15.28 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
Cervical, Pooled
|
—
|
—
|
34.07 Months
Interval 15.28 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
Vaginal/Vulvar
|
4.96 Months
Lower limit and Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
MCC
|
60.62 Months
Interval 16.72 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
25.86 Months
Interval 10.38 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Duration of Response (DoR)
NPC
|
9.46 Months
Interval 3.68 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
19.63 Months
Interval 5.55 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first dosing date to the date of death (Up to 83 months)Population: All treated participants in the metastatic cohorts
Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
Outcome measures
| Measure |
Neoadjuvant
n=113 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
n=195 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 Participants
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Metastatic: Overall Survival (OS)
Cervical, Randomized
|
21.55 Months
Interval 8.25 to 44.85
|
17.12 Months
Interval 10.22 to 34.79
|
22.74 Months
Interval 14.62 to 32.82
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
Cervical, Pooled
|
—
|
—
|
20.93 Months
Interval 14.39 to 29.04
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
Vaginal/Vulvar
|
10.28 Months
Interval 3.88 to 23.72
|
—
|
—
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
MCC
|
80.66 Months
Interval 23.26 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
29.83 Months
Interval 8.51 to 48.33
|
—
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
NPC
|
22.74 Months
Interval 12.62 to 35.29
|
23.66 Months
Interval 16.82 to 41.43
|
—
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
EBV positive related gastric cancer
|
9.99 Months
Interval 3.09 to 30.13
|
—
|
—
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
HPV positive SCCHN
|
20.44 Months
Interval 13.9 to 36.5
|
17.08 Months
Interval 9.49 to 26.78
|
—
|
8.84 Months
Interval 2.5 to 35.06
|
—
|
|
Metastatic: Overall Survival (OS)
Other anogenital HPV associated cancers
|
—
|
12.12 Months
Interval 6.83 to 29.54
|
14.06 Months
Interval 4.37 to 30.59
|
—
|
—
|
|
Metastatic: Overall Survival (OS)
SCCHN I-O naive
|
—
|
—
|
—
|
—
|
4.21 Months
Interval 1.68 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
SECONDARY outcome
Timeframe: From the first dosing date to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months)Population: All treated participants in the metastatic cohorts
Investigator-assessed progression free survival (PFS) is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST 1.1), or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
Outcome measures
| Measure |
Neoadjuvant
n=113 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
n=195 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 Participants
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
EBV positive related gastric cancer
|
2.94 Months
Interval 1.05 to 3.75
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
HPV positive SCCHN
|
3.25 Months
Interval 1.84 to 6.93
|
3.71 Months
Interval 1.77 to 6.8
|
—
|
3.81 Months
Interval 1.77 to 7.39
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Other anogenital HPV associated cancers
|
—
|
4.63 Months
Interval 1.94 to 14.29
|
3.58 Months
Interval 2.04 to 7.49
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
SCCHN I-O naive
|
—
|
—
|
—
|
—
|
1.81 Months
Interval 1.08 to
Upper limit not calculable as upper CI bound does not cross 50% threshold
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Cervical, Randomized
|
5.09 Months
Interval 1.87 to 9.07
|
3.75 Months
Interval 3.32 to 9.23
|
7.11 Months
Interval 3.71 to 17.25
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Cervical, Pooled
|
—
|
—
|
5.85 Months
Interval 3.75 to 9.03
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Vaginal/Vulvar
|
3.75 Months
Interval 1.22 to 8.15
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
MCC
|
21.32 Months
Interval 9.2 to 62.52
|
8.39 Months
Interval 3.71 to 24.34
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
NPC
|
1.94 Months
Interval 1.54 to 3.58
|
5.36 Months
Interval 2.37 to 9.23
|
—
|
—
|
—
|
POST_HOC outcome
Timeframe: From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 83 months)Population: All treated participants in the metastatic cohorts
ORR is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
Outcome measures
| Measure |
Neoadjuvant
n=113 Participants
Nivolumab administered intravenously (IV) over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
Metastatic Combo A
n=195 Participants
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 Participants
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 Participants
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 Participants
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
|---|---|---|---|---|---|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
EBV positive related gastric cancer
|
14.3 Percentage of participants
Interval 1.8 to 42.8
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
HPV positive SCCHN
|
11.5 Percentage of participants
Interval 2.4 to 30.2
|
31.0 Percentage of participants
Interval 17.6 to 47.1
|
—
|
0 Percentage of participants
Interval 0.0 to 36.9
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
Other anogenital HPV associated cancers
|
—
|
34.8 Percentage of participants
Interval 16.4 to 57.3
|
23.8 Percentage of participants
Interval 8.2 to 47.2
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
SCCHN I-O naive
|
—
|
—
|
—
|
—
|
16.7 Percentage of participants
Interval 0.4 to 64.1
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
Cervical, Randomized
|
26.3 Percentage of participants
Interval 9.1 to 51.2
|
31.1 Percentage of participants
Interval 18.2 to 46.6
|
40.0 Percentage of participants
Interval 25.7 to 55.7
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
Cervical, Pooled
|
—
|
—
|
40.2 Percentage of participants
Interval 31.0 to 49.9
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
Vaginal/Vulvar
|
20.0 Percentage of participants
Interval 0.5 to 71.6
|
—
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
MCC
|
60.0 Percentage of participants
Interval 38.7 to 78.9
|
58.1 Percentage of participants
Interval 42.1 to 73.0
|
—
|
—
|
—
|
|
Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection
NPC
|
16.7 Percentage of participants
Interval 4.7 to 37.4
|
28.6 Percentage of participants
Interval 15.7 to 44.6
|
—
|
—
|
—
|
Adverse Events
Metastatic Monotherapy
Serious events: 59 serious events
Other events: 110 other events
Deaths: 82 deaths
Metastatic Combo A
Serious events: 130 serious events
Other events: 189 other events
Deaths: 133 deaths
Metastatic Combo B
Serious events: 99 serious events
Other events: 129 other events
Deaths: 86 deaths
Metastatic Combo C
Serious events: 5 serious events
Other events: 7 other events
Deaths: 7 deaths
Metastatic Combo D
Serious events: 5 serious events
Other events: 5 other events
Deaths: 5 deaths
Neoadjuvant
Serious events: 40 serious events
Other events: 108 other events
Deaths: 40 deaths
Serious adverse events
| Measure |
Metastatic Monotherapy
n=113 participants at risk
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo A
n=195 participants at risk
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 participants at risk
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 participants at risk
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 participants at risk
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Neoadjuvant
n=123 participants at risk
Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Encephalitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Gastroenteritis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Gastroenteritis bacterial
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Kidney infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.8%
5/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Autoimmune pericarditis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Cardiac failure
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Mitral valve incompetence
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Adrenal insufficiency
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Glucocorticoid deficiency
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Thyroid disorder
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Eye disorders
Uveitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Ascites
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Colitis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.3%
11/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Immune-mediated pancreatitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Oesophageal motility disorder
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Asthenia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Chills
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Complication associated with device
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Death
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Disease progression
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Facial pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Fatigue
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
General physical health deterioration
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Hyperthermia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Malaise
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Mucosal inflammation
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Non-cardiac chest pain
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Oedema peripheral
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Pain
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Performance status decreased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Pyrexia
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Sudden death
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Autoimmune cholangitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Biliary tract disorder
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Cholecystitis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Gallbladder rupture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.5%
6/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Immune system disorders
Anaphylactic reaction
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Immune system disorders
Sarcoidosis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Abscess neck
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Bacteraemia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
COVID-19
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Cellulitis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Clostridial sepsis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Device related infection
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Device related sepsis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Large intestine infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Localised infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Medical device site infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Meningitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Osteomyelitis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Otitis media
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Periorbital infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pneumonia
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pneumonia aspiration
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pneumonia bacterial
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Post procedural infection
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pyelonephritis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Sepsis
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Septic shock
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Sinusitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Skin infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Tuberculosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Urinary tract infection
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Urosepsis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Vascular device infection
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Recall phenomenon
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood bilirubin increased
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood creatinine increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood pressure decreased
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Cytomegalovirus test positive
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
General physical condition abnormal
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
International normalised ratio increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Lipase increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Liver function test increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Troponin I increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Troponin increased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Urine output decreased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Fistula
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extranodal marginal zone B-cell lymphoma (MALT type)
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
21.2%
24/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
20.0%
39/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.8%
21/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastasis
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma of the skin
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional cell carcinoma
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour obstruction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Basal ganglia infarction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Bell's palsy
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Cerebral infarction
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Embolic stroke
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Headache
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Monoparesis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Seizure
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Syncope
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Product Issues
Device occlusion
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Acute kidney injury
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.0%
8/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Renal colic
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Renal haematoma
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Ureteric stenosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Renal and urinary disorders
Urogenital fistula
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Vulval disorder
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.5%
10/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Surgical and medical procedures
Debridement
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Arterial haemorrhage
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Embolism
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Haematoma
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Hypotension
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Iliac vein stenosis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Lymphoedema
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Orthostatic hypotension
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
Other adverse events
| Measure |
Metastatic Monotherapy
n=113 participants at risk
Nivolumab IV over 30 minutes at 240 mg every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo A
n=195 participants at risk
Nivolumab 3 mg/kg IV over 30 minutes every 2 weeks + Ipilimumab 1 mg/kg IV over 30 minutes every 6 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo B
n=133 participants at risk
Nivolumab 1 mg/kg IV over 30 minutes + Ipilimumab 3 mg/kg IV over 30 minutes every 3 weeks for 4 doses followed by Nivolumab 240 mg IV over 30 minutes every 2 weeks for a maximum of 24 months or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo C
n=8 participants at risk
Nivolumab 240 mg IV over 30 minutes + BMS-986016 (Relatlimab) 80 mg IV over 60 minutes administered every 2 weeks for a maximum of 24 months, or until disease progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Metastatic Combo D
n=6 participants at risk
Daratumumab 16 mg/kg IV weekly for the first 8 weeks. Starting at Week 3, Nivolumab 240 mg IV over 30 minutes every 2 weeks. Daratumumab 16 mg/kg every 2 weeks from Weeks 9-24. Starting at Week 25, Nivolumab 480 mg IV flat dose over 30 minutes every 4 weeks; daratumumab 16 mg/kg every 4 weeks for a maximum of 24 months or until progression, unacceptable toxicity, or withdrawal of consent, whichever comes first
|
Neoadjuvant
n=123 participants at risk
Nivolumab IV over 30 minutes at 240 mg for 2 doses, on Day 1 and Day 15
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.8%
28/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
27.2%
53/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
31.6%
42/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.9%
11/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Ear and labyrinth disorders
Ear pain
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Ear and labyrinth disorders
Vertigo
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Hyperthyroidism
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.8%
21/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Endocrine disorders
Hypothyroidism
|
15.0%
17/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
20.0%
39/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
23.3%
31/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Abdominal pain
|
15.9%
18/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
14.4%
28/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
22.6%
30/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.5%
8/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
10.6%
12/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.8%
5/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Colitis
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Constipation
|
23.9%
27/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
26.2%
51/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
27.8%
37/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.1%
21/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
27.4%
31/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
31.3%
61/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
40.6%
54/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.9%
22/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Dry mouth
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.7%
13/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.5%
6/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Dysphagia
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.2%
12/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
50.0%
4/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.1%
21/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Nausea
|
22.1%
25/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
23.1%
45/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
36.1%
48/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
50.0%
3/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
34.1%
42/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Stomatitis
|
6.2%
7/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.1%
5/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Gastrointestinal disorders
Vomiting
|
18.6%
21/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.9%
31/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
24.8%
33/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
11.4%
14/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Asthenia
|
15.9%
18/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
13.3%
26/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.3%
23/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.9%
11/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Chest pain
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Chills
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.8%
9/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Face oedema
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Facial pain
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Fatigue
|
41.6%
47/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
41.5%
81/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
34.6%
46/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
75.0%
6/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
32.5%
40/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Gait disturbance
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Inflammation
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Influenza like illness
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.2%
12/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Localised oedema
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.5%
8/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Malaise
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Mucosal inflammation
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.8%
5/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.2%
15/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Non-cardiac chest pain
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Oedema peripheral
|
14.2%
16/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.8%
21/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.0%
20/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Pain
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
General disorders
Pyrexia
|
12.4%
14/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.4%
34/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
24.8%
33/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.6%
13/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Bronchitis
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Candida infection
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Conjunctivitis
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Eye infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Mucosal infection
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Nasopharyngitis
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.2%
14/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Oral bacterial infection
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Otitis externa
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Respiratory tract infection
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Rhinitis
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Tracheitis
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Upper respiratory tract infection
|
6.2%
7/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
13.8%
27/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.0%
8/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Infections and infestations
Urinary tract infection
|
8.0%
9/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.8%
21/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
23.3%
31/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.3%
9/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.3%
9/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.2%
15/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Alanine aminotransferase increased
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
13.3%
26/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.5%
22/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Amylase increased
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.3%
20/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.0%
12/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.7%
7/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Aspartate aminotransferase increased
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.8%
25/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.0%
20/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood alkaline phosphatase increased
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Blood creatinine increased
|
9.7%
11/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.7%
19/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.8%
13/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Lipase increased
|
15.0%
17/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
13.8%
27/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.8%
17/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.7%
7/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Lymphocyte count decreased
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.2%
16/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Platelet count decreased
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Troponin increased
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
Weight decreased
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.3%
24/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.0%
8/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.2%
15/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Investigations
White blood cell count decreased
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
21.2%
24/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
24.6%
48/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
24.1%
32/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.2%
15/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.5%
8/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.2%
16/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.8%
9/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.2%
14/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.0%
16/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.3%
20/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
11.3%
15/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.9%
11/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.2%
14/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.8%
17/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.1%
10/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.3%
24/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.5%
14/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.3%
9/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.3%
20/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
21.2%
24/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
17.9%
35/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
19.5%
26/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.1%
10/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.0%
17/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
14.4%
28/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
14.3%
19/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.7%
19/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.5%
10/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.6%
12/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.7%
13/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.8%
9/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.51%
1/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
6.2%
7/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Dizziness
|
10.6%
12/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.7%
19/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
11.3%
15/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Dysgeusia
|
6.2%
7/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.1%
10/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Headache
|
11.5%
13/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.9%
31/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.5%
22/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Paraesthesia
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.5%
8/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Psychiatric disorders
Anxiety
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.1%
8/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.3%
9/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Psychiatric disorders
Confusional state
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.6%
5/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
2/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Psychiatric disorders
Insomnia
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
11.8%
23/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.0%
8/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Pelvic pain
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.0%
26/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.1%
49/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.8%
17/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.7%
7/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.6%
21/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
15.4%
30/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.8%
13/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.0%
2/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
6.2%
7/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.6%
11/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.3%
6/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.3%
3/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.6%
9/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
6.8%
9/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.7%
3/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.3%
7/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.1%
6/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
7.2%
14/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.0%
12/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.4%
3/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.5%
3/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.81%
1/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
20.4%
23/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
30.8%
60/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
26.3%
35/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
8.9%
11/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.0%
17/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
25.1%
49/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.0%
16/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.7%
7/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
7.1%
8/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
10.3%
20/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
18.8%
25/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
4.9%
6/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.75%
1/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
33.3%
2/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Haematoma
|
1.8%
2/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.0%
2/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Hypertension
|
8.8%
10/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.6%
7/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.8%
5/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
9.8%
12/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Hypotension
|
4.4%
5/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
5.1%
10/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.0%
4/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.3%
4/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Lymphoedema
|
3.5%
4/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
2.1%
4/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
3.8%
5/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
12.5%
1/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
1.6%
2/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
|
Vascular disorders
Venous thrombosis
|
0.88%
1/113 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/195 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/133 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/8 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
16.7%
1/6 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
0.00%
0/123 • SAEs and Other AEs are assessed from first dose to 100 days post last dose (Up to 83 months) Participants were assessed for all-cause mortality from their first dose to their study completion (Up to 84 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER