Trial Outcomes & Findings for Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer (NCT NCT04223856)
NCT ID: NCT04223856
Last Updated: 2025-06-13
Results Overview
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
886 participants
Primary outcome timeframe
From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)
Results posted on
2025-06-13
Participant Flow
Participants with untreated locally advanced or metastatic urothelial cancer (UC) were enrolled in the study.
Results are reported only for primary outcome measures at primary completion date (08-Aug-2023). Remaining secondary outcome measures whose analysis are not final, results would be reported at study completion date.
Participant milestones
| Measure |
Enfortumab Vedotin + Pembrolizumab
Participants received enfortumab vedotin at 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (area under curve \[AUC\] 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
442
|
444
|
|
Overall Study
Treated
|
440
|
433
|
|
Overall Study
COMPLETED
|
8
|
244
|
|
Overall Study
NOT COMPLETED
|
434
|
200
|
Reasons for withdrawal
| Measure |
Enfortumab Vedotin + Pembrolizumab
Participants received enfortumab vedotin at 1.25 milligram per kilogram (mg/kg) as an intravenous (IV) infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (area under curve \[AUC\] 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Overall Study
Progressive disease
|
153
|
73
|
|
Overall Study
Adverse Event
|
97
|
62
|
|
Overall Study
Physician Decision
|
9
|
28
|
|
Overall Study
Withdrawal by Subject
|
22
|
24
|
|
Overall Study
Other
|
7
|
2
|
|
Overall Study
Randomized but not treated
|
2
|
11
|
|
Overall Study
On-treatment
|
144
|
0
|
Baseline Characteristics
Enfortumab Vedotin and Pembrolizumab vs. Chemotherapy Alone in Untreated Locally Advanced or Metastatic Urothelial Cancer
Baseline characteristics by cohort
| Measure |
Enfortumab Vedotin + Pembrolizumab
n=442 Participants
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
n=444 Participants
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
Total
n=886 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.9 Years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
68.0 Years
STANDARD_DEVIATION 9.4 • n=107 Participants
|
67.9 Years
STANDARD_DEVIATION 9.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
108 Participants
n=107 Participants
|
206 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
344 Participants
n=99 Participants
|
336 Participants
n=107 Participants
|
680 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
52 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
104 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
359 Participants
n=99 Participants
|
343 Participants
n=107 Participants
|
702 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
31 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
80 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
99 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
191 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
3 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
308 Participants
n=99 Participants
|
290 Participants
n=107 Participants
|
598 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Multiple
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
22 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
59 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum exposure to treatment was up to 39.2 months)Population: ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
PFS was defined as the time from date of randomization to first documentation of disease progression (PD), or to death due to any cause, whichever occurred first. PD: at least a 20 percent (%) increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 millimeter (mm). PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Enfortumab Vedotin + Pembrolizumab
n=442 Participants
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
n=444 Participants
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Blinded Independent Central Review (BICR)
|
12.5 Months
Interval 10.4 to 16.6
|
6.3 Months
Interval 6.2 to 6.5
|
PRIMARY outcome
Timeframe: From randomization to date of death due to any cause or censoring date, whichever occurred first (maximum exposure to treatment was up to 39.2 months)Population: ITT analysis set included all randomized participants. Participants were analyzed according to the treatment arm assigned at randomization regardless of the actual treatment received.
OS was defined as the time from the date of randomization to the date of death from any cause. In the absence of death, OS was censored at the date the participant was last known to be alive. Kaplan-Meier method was used for analysis.
Outcome measures
| Measure |
Enfortumab Vedotin + Pembrolizumab
n=442 Participants
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
n=444 Participants
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Overall Survival (OS)
|
31.5 Months
Interval 25.4 to
Upper limit of 95% CI could not be estimated due to insufficient number of participants with event.
|
16.1 Months
Interval 13.9 to 18.3
|
SECONDARY outcome
Timeframe: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)ORR as per RECIST v1.1 by BICR was defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30 percent \[%\] decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to date of pain progression (maximum up to approximately 7.4 years)TTPP was defined as the time from the date of randomization to date of pain progression. Pain progression was defined as a participant reporting either of the following, whichever came first: 1) Increase of 2 or more points from baseline on Brief Pain Inventory - Short Form (BPI-SF) Question 3 (i.e., pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels) maintained for at least two consecutive assessments. 2) Initiation of new opioid medication from baseline for pain with usage maintained for at least two consecutive assessments as recorded in BPI-SF Question 7 (i.e., What medications received for pain).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 26Brief Pain Inventory (BPI-SF) was defined as summary of the worst, least, and average pain experienced in the last 24 hours as well as pain right now and number of pain locations were provided for each treatment arm. BPI-sf worst pain measured the severity of pain based on the pain at its worst in the last 24 hours, score range 0 to 10 with higher scores associated with higher pain levels.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to first documentation of PD or death due to any cause, whichever occurred first (maximum up to approximately 7.4 years)PFS as per RECIST v1.1 by investigator was defined as the time from date of randomization to first documentation of PD, or to death due to any cause, whichever comes first. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. PD could also be unequivocal progression of non-target lesions or the presence of unequivocal new lesions.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose till CR/PR or PD or death, whichever occurred first (maximum up to approximately 7.4 years)ORR as per RECIST v1.1 by investigator was defined as the percentage of participants with confirmed CR or PR. CR was defined as disappearance of all lesions including non-target lesions (not just target lesions). Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per BICR or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of first documented response of CR or PR to the first documented disease progression or to death from any cause, whichever occurred first (maximum up to approximately 7.4 years)DOR was defined as the time from the first objective response (CR or PR that is subsequently confirmed) to the first documented PD per RECIST v1.1 per investigator or death from any cause, whichever occurs first. DOR will only include subjects with a confirmed response (CR or PR per RECIST v1.1). CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. PD: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (\>30% shrinkage) nor progression (\>20% growth).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From the date of randomization to the date of PD or death from any cause or censoring date, whichever occurred first (maximum up to approximately 7.4 years)DCR by BICR was defined as the percentage of participants with confirmed response (CR or PR), or SD (or non-CR/non-PD), per RECIST v1.1. Subjects who have no post-baseline response assessments will be considered as non-responders for calculating the DCR. Only response assessments before the first documented PD or subsequent anticancer therapies were considered. CR was defined as disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to\<10 mm. PR was defined as at least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. For a response to be considered as confirmed, the subsequent response needs to be at least 4 weeks after the initial response. SD was defined as a change in tumor size that is neither radiological response (\>30% shrinkage) nor progression (\>20% growth).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of study (approximately up to 7.4 years)The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, End of study (approximately up to 7.4 years)The EQ-5D-5L is a 5-item self-reported measure of functioning and well-being, which assesses 5 dimensions of health, including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression (EQ-5D-5L User Guide, 2019). Each dimension comprises 5 levels (no problems, slight problems, moderate problems, severe problems, and extreme problems).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of study (approximately up to 7.4 years)EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, End of study (approximately up to 7.4 years)EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status (GHS), symptom scales (fatigue, pain, nausea/vomiting), and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea, and financial difficulties). Most questions used 4- point scale (1 'Not at All' to 4 'Very Much'); 2 questions used 7-point scale (1 'Very Poor' to 7 'Excellent'). Scores averaged, transformed to 0- 100 scale; higher score=better level of functioning or greater degree of symptoms. Change from baseline=Cycle/Day score minus baseline score.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 37 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per common terminology criteria for adverse events (CTCAE) version 4, Grade 3= severe AE; Grade 4= life-threatening or disabling AE; Grade 5= death related to an AE.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment relatedness was assessed by the investigator.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of treatment up to 37 days after last dose of study drug (approximately up to 7.4 years)Laboratory abnormalities included Hematology and Serum Chemistry. In Hematology (increased : hemoglobin, lymphocytes, leukocytes, and decreased : hemoglobin, lymphocytes, neutrophils, platelets and leukocytes) and In serum chemistry (increased in : alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium corrected for albumin, creatinine, glucose (non-fasting), potassium, sodium, and decreased in albumin, calcium corrected for albumin, glucose (non-fasting), potassium, phosphate and sodium).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During study (approximately up to 7.4 years)Outcome measures
Outcome data not reported
Adverse Events
Enfortumab Vedotin + Pembrolizumab
Serious events: 220 serious events
Other events: 435 other events
Deaths: 133 deaths
Standard of Care
Serious events: 169 serious events
Other events: 418 other events
Deaths: 226 deaths
Serious adverse events
| Measure |
Enfortumab Vedotin + Pembrolizumab
n=440 participants at risk
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
n=433 participants at risk
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
3/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.9%
17/433 • Number of events 18 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.91%
4/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.8%
12/433 • Number of events 12 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.6%
7/433 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.0%
13/433 • Number of events 13 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Acute right ventricular failure
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Cardiac arrest
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Cardiac failure
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Immune-mediated myocarditis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Myocardial infarction
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Myocarditis
|
0.45%
2/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Ear and labyrinth disorders
Vertigo
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Endocrine disorders
Hypothyroidism
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Eye disorders
Keratitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
8/440 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Ascites
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Colitis
|
0.68%
3/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Colitis ulcerative
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.2%
14/440 • Number of events 15 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Duodenitis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Immune-mediated enterocolitis
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Large intestinal ulcer haemorrhage
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Malignant gastrointestinal obstruction
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Nausea
|
0.91%
4/440 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Rectal ulcer haemorrhage
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
1.1%
5/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Asthenia
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Condition aggravated
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Death
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Fatigue
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
General physical health deterioration
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.6%
7/433 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Malaise
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Oedema peripheral
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Performance status decreased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Pyrexia
|
2.0%
9/440 • Number of events 10 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.3%
10/433 • Number of events 15 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Sudden death
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Cholangitis sclerosing
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Hepatitis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Immune system disorders
Sarcoidosis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Bacteraemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
COVID-19
|
1.8%
8/440 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.1%
5/440 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Campylobacter gastroenteritis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Cellulitis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Clostridium difficile infection
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Cystitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Cytomegalovirus colitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Device related infection
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Diverticulitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Enterocolitis infectious
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Infectious pleural effusion
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Kidney infection
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Neutropenic sepsis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pelvic infection
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Perineal abscess
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pneumonia
|
2.3%
10/440 • Number of events 10 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pneumonia aspiration
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pyelonephritis
|
0.91%
4/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.4%
6/433 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Pyelonephritis acute
|
0.23%
1/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Sepsis
|
1.6%
7/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.8%
8/433 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Septic shock
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Skin infection
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urinary tract infection
|
3.6%
16/440 • Number of events 16 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
7.2%
31/433 • Number of events 39 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urinary tract infection staphylococcal
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urosepsis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Wound infection
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Heat stroke
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Sternal fracture
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Injury, poisoning and procedural complications
Urinary tract stoma complication
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Alanine aminotransferase increased
|
1.1%
5/440 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
1.1%
5/440 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Blood bilirubin increased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Blood creatinine increased
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Lipase increased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Neutrophil count decreased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Oxygen saturation decreased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Platelet count decreased
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Prothrombin time prolonged
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Weight decreased
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
1.8%
8/440 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.68%
3/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.4%
6/440 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.1%
5/440 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic lymphocytic leukaemia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour rupture
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Diabetic hyperglycaemic coma
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Immune-mediated encephalitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Immune-mediated neuropathy
|
0.23%
1/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Nervous system disorder
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Optic neuritis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Partial seizures
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Peripheral sensorimotor neuropathy
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Seizure
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Syncope
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Psychiatric disorders
Anxiety
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Psychiatric disorders
Confusional state
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Psychiatric disorders
Delirium
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Psychiatric disorders
Disorientation
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.2%
23/440 • Number of events 27 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.5%
11/433 • Number of events 13 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Calculus bladder
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Haematuria
|
1.6%
7/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.3%
10/433 • Number of events 10 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Immune-mediated nephritis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Postrenal failure
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Renal failure
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Renal impairment
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Urinary retention
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Urinoma
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Reproductive system and breast disorders
Prostatitis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.91%
4/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Immune-mediated lung disease
|
1.1%
5/440 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.91%
4/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Lung opacity
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal dyskinesia
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
9/440 • Number of events 10 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.6%
7/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.4%
6/433 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis bullous
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.6%
7/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
SJS-TEN overlap
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.68%
3/440 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Toxic erythema of chemotherapy
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Aortic aneurysm rupture
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Hypotension
|
0.45%
2/440 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Iliac artery occlusion
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Lymphocele
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Lymphoedema
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Orthostatic hypotension
|
0.23%
1/440 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Vascular disorders
Shock
|
0.00%
0/440 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
Other adverse events
| Measure |
Enfortumab Vedotin + Pembrolizumab
n=440 participants at risk
Participants received enfortumab vedotin at 1.25 mg/kg as an IV infusion over approximately 30 minutes on Days 1 and 8 of each cycle, and pembrolizumab 200 mg as an IV infusion over approximately 30 minutes on Day 1 of each cycle, after completion of the enfortumab vedotin infusion. 1 cycle = 3 weeks.
|
Standard of Care
n=433 participants at risk
Participants received gemcitabine at 1000 mg/m\^2 as an IV infusion on Days 1 and 8 of each cycle, and either cisplatin (70 mg/m\^2) or carboplatin (AUC 4.5, or AUC 5 according to local guidelines) on Day 1 of each cycle, with adequate pre- and post-hydration, by IV infusion per institutional standards. 1 cycle = 3 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
24.1%
106/440 • Number of events 168 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
58.9%
255/433 • Number of events 362 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.6%
16/440 • Number of events 25 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
10.9%
47/433 • Number of events 91 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Neutropenia
|
9.8%
43/440 • Number of events 70 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
41.1%
178/433 • Number of events 360 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.3%
19/440 • Number of events 21 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
33.9%
147/433 • Number of events 266 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.4%
6/440 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.7%
29/433 • Number of events 31 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Endocrine disorders
Hypothyroidism
|
10.2%
45/440 • Number of events 47 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Eye disorders
Cataract
|
5.0%
22/440 • Number of events 23 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.23%
1/433 • Number of events 1 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Eye disorders
Dry eye
|
11.4%
50/440 • Number of events 52 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Eye disorders
Lacrimation increased
|
8.2%
36/440 • Number of events 42 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.46%
2/433 • Number of events 2 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Eye disorders
Vision blurred
|
5.9%
26/440 • Number of events 28 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.2%
5/433 • Number of events 5 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
44/440 • Number of events 52 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.8%
25/433 • Number of events 30 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Constipation
|
26.4%
116/440 • Number of events 136 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
33.7%
146/433 • Number of events 168 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.6%
161/440 • Number of events 237 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
15.5%
67/433 • Number of events 78 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Dry mouth
|
9.3%
41/440 • Number of events 41 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.6%
7/433 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
25/440 • Number of events 26 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
4.2%
18/433 • Number of events 20 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Nausea
|
25.9%
114/440 • Number of events 144 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
40.6%
176/433 • Number of events 233 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Stomatitis
|
8.9%
39/440 • Number of events 46 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.2%
27/433 • Number of events 31 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
48/440 • Number of events 57 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
15.5%
67/433 • Number of events 95 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Asthenia
|
17.0%
75/440 • Number of events 123 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
19.4%
84/433 • Number of events 112 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Fatigue
|
34.5%
152/440 • Number of events 182 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
38.6%
167/433 • Number of events 199 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Oedema peripheral
|
13.6%
60/440 • Number of events 72 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
10.9%
47/433 • Number of events 57 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
General disorders
Pyrexia
|
16.4%
72/440 • Number of events 97 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
13.9%
60/433 • Number of events 72 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
COVID-19
|
12.5%
55/440 • Number of events 59 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.7%
16/433 • Number of events 16 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Conjunctivitis
|
6.1%
27/440 • Number of events 30 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Infections and infestations
Urinary tract infection
|
17.3%
76/440 • Number of events 96 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
14.8%
64/433 • Number of events 92 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Alanine aminotransferase increased
|
16.8%
74/440 • Number of events 123 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
7.6%
33/433 • Number of events 52 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Aspartate aminotransferase increased
|
15.0%
66/440 • Number of events 106 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.2%
27/433 • Number of events 45 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.0%
22/440 • Number of events 33 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.7%
16/433 • Number of events 19 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Blood creatinine increased
|
8.4%
37/440 • Number of events 49 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
11.3%
49/433 • Number of events 58 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Neutrophil count decreased
|
3.4%
15/440 • Number of events 20 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
12.9%
56/433 • Number of events 109 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Platelet count decreased
|
0.91%
4/440 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
14.1%
61/433 • Number of events 94 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
Weight decreased
|
32.7%
144/440 • Number of events 152 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
8.8%
38/433 • Number of events 38 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Investigations
White blood cell count decreased
|
1.1%
5/440 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.8%
25/433 • Number of events 45 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.3%
142/440 • Number of events 168 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
25.9%
112/433 • Number of events 136 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
15.5%
68/440 • Number of events 101 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.5%
11/433 • Number of events 13 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.0%
35/440 • Number of events 57 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.8%
25/433 • Number of events 30 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.1%
18/440 • Number of events 27 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.2%
27/433 • Number of events 31 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
8.2%
36/440 • Number of events 54 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.0%
26/433 • Number of events 38 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
6.8%
30/440 • Number of events 41 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.9%
17/433 • Number of events 20 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.0%
57/440 • Number of events 72 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
4.8%
21/433 • Number of events 23 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
11.4%
50/440 • Number of events 60 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
7.6%
33/433 • Number of events 33 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.4%
28/440 • Number of events 28 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.6%
7/433 • Number of events 8 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
26/440 • Number of events 30 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
2.5%
11/433 • Number of events 15 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
31/440 • Number of events 37 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.3%
23/433 • Number of events 26 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Dizziness
|
8.2%
36/440 • Number of events 38 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
9.9%
43/433 • Number of events 46 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Dysgeusia
|
21.1%
93/440 • Number of events 106 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
8.5%
37/433 • Number of events 38 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Headache
|
7.5%
33/440 • Number of events 42 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.0%
26/433 • Number of events 27 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Paraesthesia
|
8.2%
36/440 • Number of events 39 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.8%
8/433 • Number of events 9 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
51.8%
228/440 • Number of events 271 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
10.2%
44/433 • Number of events 44 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Psychiatric disorders
Insomnia
|
10.2%
45/440 • Number of events 47 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.5%
24/433 • Number of events 24 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.91%
4/440 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.3%
23/433 • Number of events 29 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Renal and urinary disorders
Haematuria
|
11.8%
52/440 • Number of events 67 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
7.9%
34/433 • Number of events 42 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.3%
54/440 • Number of events 60 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
5.1%
22/433 • Number of events 23 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.0%
22/440 • Number of events 25 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.3%
54/440 • Number of events 63 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
10.9%
47/433 • Number of events 55 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.5%
11/440 • Number of events 11 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.2%
27/433 • Number of events 27 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
3.0%
13/440 • Number of events 15 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.7%
29/433 • Number of events 31 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.5%
152/440 • Number of events 154 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
7.9%
34/433 • Number of events 34 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.3%
76/440 • Number of events 84 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.4%
6/433 • Number of events 6 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
6.4%
28/440 • Number of events 33 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.92%
4/433 • Number of events 4 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
41.4%
182/440 • Number of events 259 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
6.7%
29/433 • Number of events 33 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
9.8%
43/440 • Number of events 57 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
1.4%
6/433 • Number of events 7 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
32.5%
143/440 • Number of events 208 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
3.5%
15/433 • Number of events 15 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
7.7%
34/440 • Number of events 42 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.69%
3/433 • Number of events 3 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
5.5%
24/440 • Number of events 27 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
0.00%
0/433 • From start of treatment up to 37 days after last dose of study drug (up to 40 months 9 days)
Same event may appear as both non-serious adverse event (SAE) and SAE; however, what is presented are distinct events. An event may be categorized as serious in 1 participant and non-serious in other participant, or a participant may have experienced both SAE and non-SAE. Data for all-cause mortality was collected for all enrolled participants, data for SAE and non-SAE were collected for treated participants.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place