Trial Outcomes & Findings for Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study) (NCT NCT01964430)
NCT ID: NCT01964430
Last Updated: 2023-06-28
Results Overview
Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
866 participants
Primary outcome timeframe
Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alone
Results posted on
2023-06-28
Participant Flow
The study randomized participants at 160 sites in 21 countries: Australia, Austria, Belgium, Canada, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, Hungary, Ireland, Italy, Netherlands, Portugal, Singapore, Republic of Korea, Spain, Taiwan, United Kingdom and the US.
Participants were randomized using a stratified randomization with a 1:1 ratio to either nab-paclitaxel followed by gemcitabine, or gemcitabine alone. Stratification factors were tumor resection status (R0 versus R1), nodal status lymph node positive versus lymph node negative, and region \[North America, Europe, and Australia versus Asia Pacific\]).
Participant milestones
| Measure |
Nab-Paclitaxel and Gemcitabine
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Pre-Treatment (Randomization) Period
STARTED
|
432
|
434
|
|
Pre-Treatment (Randomization) Period
COMPLETED
|
429
|
423
|
|
Pre-Treatment (Randomization) Period
NOT COMPLETED
|
3
|
11
|
|
Treatment Period
STARTED
|
429
|
423
|
|
Treatment Period
COMPLETED
|
287
|
310
|
|
Treatment Period
NOT COMPLETED
|
142
|
113
|
Reasons for withdrawal
| Measure |
Nab-Paclitaxel and Gemcitabine
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Pre-Treatment (Randomization) Period
Protocol Deviation
|
0
|
2
|
|
Pre-Treatment (Randomization) Period
Withdrawal by Subject
|
2
|
9
|
|
Pre-Treatment (Randomization) Period
Adverse Event
|
1
|
0
|
|
Treatment Period
Adverse Event
|
71
|
37
|
|
Treatment Period
Withdrawal by Subject
|
36
|
27
|
|
Treatment Period
Death
|
1
|
3
|
|
Treatment Period
Protocol Deviation
|
0
|
1
|
|
Treatment Period
Physician Decision
|
5
|
4
|
|
Treatment Period
Disease Relapse
|
28
|
38
|
|
Treatment Period
Other reasons
|
1
|
3
|
Baseline Characteristics
Nab-paclitaxel and Gemcitabine vs Gemcitabine Alone as Adjuvant Therapy for Patients With Resected Pancreatic Cancer (the "Apact" Study)
Baseline characteristics by cohort
| Measure |
Nab-Paclitaxel and Gemcitabine
n=432 Participants
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=434 Participants
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Total
n=866 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.4 Years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
62.9 Years
STANDARD_DEVIATION 8.84 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 9.21 • n=5 Participants
|
|
Sex: Female, Male
Female
|
204 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
385 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=5 Participants
|
253 Participants
n=7 Participants
|
481 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
400 Participants
n=5 Participants
|
393 Participants
n=7 Participants
|
793 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
60 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
333 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
672 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
11 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Collected or Reported
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Region of Enrollment
North America
|
144 Participants
n=5 Participants
|
156 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
203 Participants
n=5 Participants
|
205 Participants
n=7 Participants
|
408 Participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
30 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Asia Pacific
|
55 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Body Surface Area (BSA)
|
1.77 m²
STANDARD_DEVIATION 0.226 • n=5 Participants
|
1.78 m²
STANDARD_DEVIATION 0.221 • n=7 Participants
|
1.78 m²
STANDARD_DEVIATION 0.224 • n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0 = Fully Active
|
252 Participants
n=5 Participants
|
268 Participants
n=7 Participants
|
520 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1 = Restricted but Ambulatory
|
180 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
346 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
2 = Ambulatory but Unable to Work
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
3 = Limited Self-care
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
4 = Completely Disabled
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Grade 0
|
404 Participants
n=5 Participants
|
408 Participants
n=7 Participants
|
812 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Grade 1
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Grade 2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Grade 3
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Physician Assessment of Peripheral Neuropathy
Missing
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Time from Surgery to Randomization
|
57.0 Days
n=5 Participants
|
56.0 Days
n=7 Participants
|
57.0 Days
n=5 Participants
|
|
TNM Classification
T1 = Tumor is 2 cm or smaller
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
TNM Classification
T2 = Tumor is > 2 cm, but not larger than 5 cm
|
38 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
|
TNM Classification
T3 = Tumor is larger than 5 cm
|
377 Participants
n=5 Participants
|
384 Participants
n=7 Participants
|
761 Participants
n=5 Participants
|
|
TNM Classification
T4 = Tumor is any size, but has spread
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Nodal Status
Lymph Node Positive (LN+)
|
311 Participants
n=5 Participants
|
312 Participants
n=7 Participants
|
623 Participants
n=5 Participants
|
|
Nodal Status
Lymph Node Negative (LN-)
|
121 Participants
n=5 Participants
|
122 Participants
n=7 Participants
|
243 Participants
n=5 Participants
|
|
Resection Status
R0 (tumor-negative resection margin)
|
327 Participants
n=5 Participants
|
334 Participants
n=7 Participants
|
661 Participants
n=5 Participants
|
|
Resection Status
R1 (tumor- positive resection margin)
|
105 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Date of randomization up to data cut off date of 31 December 2018; median DFS follow-up time for censored participants was 22.242 months for nab-Paclitaxel and gemcitabine and 13.832 months for gemcitabine alonePopulation: The intent-to-treat population consisted of all randomized participants regardless of whether they received any investigational product (IP) or had any efficacy assessment collected.
Disease free survival was defined as the time from the date of randomization to the date of disease recurrence or death, whichever occurred earlier. Disease recurrence was determined by the independent radiological review of computed tomography (CT) or magnetic resonance imaging (MRI) scans. Participants who did not have disease recurrence or did not die were censored at the last tumor assessment date with disease-free status or the randomization date if the last tumor assessment with disease-free status was missing. Disease-free status referred to a status that was neither being disease recurrent nor indeterminate or not evaluable. Participants who received new anti-cancer therapy or cancer-related surgery prior to disease recurrence or death were censored at the date of last tumor assessment with disease-free status prior to the start of new anti-cancer therapy or cancer-related surgery or the randomization date.
Outcome measures
| Measure |
Nab-Paclitaxel and Gemcitabine
n=432 Participants
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=434 Participants
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Kaplan Meier Estimate for Disease Free Survival (DFS) According to the Independent Radiological Review Committee
|
19.4 months
Interval 16.62 to 21.91
|
18.8 months
Interval 13.83 to 20.3
|
SECONDARY outcome
Timeframe: From randomization to date of death; median OS follow-up time for censored participants was 77.832 months for nab-Paclitaxel and gemcitabine and 77.799 months for gemcitabine alonePopulation: The intent-to-treat population consisted of all randomized participants regardless of whether the participant received any IP or had any efficacy assessment collected.
Overall survival was defined as the time from the date of randomization to the date of death. Participants who were alive at the end of study or clinical data cut were censored on the last-known-to-be-alive date or the clinical cutoff date, whichever was earlier.
Outcome measures
| Measure |
Nab-Paclitaxel and Gemcitabine
n=432 Participants
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=434 Participants
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Kaplan Meier Estimate of Overall Survival (OS)
50th Quartile
|
41.8 months
Interval 35.55 to 47.28
|
37.7 months
Interval 31.11 to 40.51
|
|
Kaplan Meier Estimate of Overall Survival (OS)
75th Quartile
|
90.2 months
Interval 83.55 to
Insufficient number of participants with events
|
83.0 months
Interval 61.93 to
Insufficient number of participants with events
|
|
Kaplan Meier Estimate of Overall Survival (OS)
25th Quartile
|
20.7 months
Interval 19.38 to 22.83
|
17.7 months
Interval 14.78 to 19.91
|
SECONDARY outcome
Timeframe: From day 1 of study drug up to 28 days after the last dose of study drug; up to the data cut off date of 31 December 2018 (up to approximately 37 weeks).Population: Treated Population consisted of randomized participants who received at least one dose of study drug.
TEAEs are defined as any adverse event (AE) that begin or worsen on or after the start of study drug or procedure of the study period through the maximum duration of the period plus 28 days. The severity of AEs was graded based on National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), Version 4.0 and the scale: Grade 1 = Mild Grade 2 = Moderate Grade 3 = Severe Grade 4 = Life threatening Grade 5 = Death. Relation to study drug was determined by the investigator. A treatment-related TEAE is defined as TEAE which was considered to be related to one or both of the study drugs and reported as 'Suspected' on the case report form. AEs with a missing relationship were treated as 'treatment-related' in data summaries. IP (investigational product) refers to nab-Paclitaxel and/or Gemcitabine. "Related" TEAE refers to relation to study drug (IP).
Outcome measures
| Measure |
Nab-Paclitaxel and Gemcitabine
n=429 Participants
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=423 Participants
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 TEAE
|
429 Participants
|
417 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Related TEAE
|
423 Participants
|
399 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 TEAE of Severity Grade 3 or Higher
|
371 Participants
|
286 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥ 1 Related TEAE of Severity Grade 3 or Higher
|
332 Participants
|
239 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Serious TEAE
|
176 Participants
|
96 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Serious Related TEAE
|
102 Participants
|
55 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 TEAE Leading to Withdrawal of IP
|
117 Participants
|
43 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Related TEAE Leading to Withdrawal of IP
|
98 Participants
|
35 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 TEAE Lead Dose Reduction: nab-Paclitaxel or Gem
|
276 Participants
|
210 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Related TEAE Dose Reduct: nab-Paclitaxel or Gem
|
270 Participants
|
205 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
TEAE Lead Dose Interruption nab-Paclitaxel or Gem
|
266 Participants
|
158 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
≥1 Related TEAE Dose Interruption to IP
|
221 Participants
|
125 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
TEAE Leading to Death
|
2 Participants
|
2 Participants
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAE's)
>=1 Related TEAE Leading to Death
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: From day 1 of study drug up to 28 days after the last dose of study drug, or the treatment discontinuation date, whichever was later (up to approximately 37 weeks).Population: All treated participants with at least one post-baseline value and received at least one dose of investigational product (IP).
The number of participants with grade 3-4 laboratory abnormalities in selected clinically significant parameters. Grades for chemistry parameters were coded using National Cancer Institute Common Terminology Criteria for Adverse Events (Grade 3= severe, Grade 4= life-threatening).
Outcome measures
| Measure |
Nab-Paclitaxel and Gemcitabine
n=421 Participants
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=416 Participants
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Alkaline phosphatase
|
7 Participants
|
3 Participants
|
|
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Alanine aminotransferase
|
9 Participants
|
3 Participants
|
|
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Aspartate aminotransferase
|
9 Participants
|
2 Participants
|
|
The Number of Participants With Clinical Chemistry Laboratory-Detected Abnormalities (Grade 3-4)
Bilirubin
|
0 Participants
|
1 Participants
|
Adverse Events
Nab-Paclitaxel and Gemcitabine
Serious events: 181 serious events
Other events: 426 other events
Deaths: 285 deaths
Gemcitabine
Serious events: 96 serious events
Other events: 407 other events
Deaths: 297 deaths
Serious adverse events
| Measure |
Nab-Paclitaxel and Gemcitabine
n=429 participants at risk
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=423 participants at risk
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.8%
12/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Anaemia of malignant disease
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.7%
16/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Haemolytic uraemic syndrome
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Microangiopathic haemolytic anaemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
5/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
5/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina pectoris
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Angina unstable
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial fibrillation
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrial thrombosis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.95%
4/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Left ventricular failure
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Cardiac disorders
Tachycardia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.6%
7/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.95%
4/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Anastomotic ulcer perforation
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Colitis
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.8%
12/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Enteritis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haematochezia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Ileus
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Internal hernia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Intra-abdominal fluid collection
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Jejunal perforation
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatic pseudocyst
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Proctitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
8/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chills
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
1.6%
7/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
General physical health deterioration
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Generalised oedema
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Impaired healing
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Malaise
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
1.2%
5/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Peripheral swelling
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Polyserositis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
6.8%
29/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
24/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Immune system disorders
Drug hypersensitivity
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal abscess
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Abdominal infection
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Arthritis bacterial
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bacteraemia
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Biliary tract infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Bronchitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Catheter site infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cellulitis
|
1.9%
8/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
5/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cholera
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Clostridium difficile infection
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Colonic abscess
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Corona virus infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Cystitis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related infection
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Device related sepsis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Enterocolitis infectious
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Escherichia sepsis
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Febrile infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastroenteritis clostridial
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Herpes zoster
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infection
|
2.1%
9/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infectious colitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Influenza
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella bacteraemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Klebsiella sepsis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Liver abscess
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Lung infection
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Neutropenic sepsis
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pancreatic abscess
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Periodontitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Peritonitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Pneumonia
|
2.1%
9/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Post procedural infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Postoperative abscess
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Respiratory tract infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Sepsis
|
2.8%
12/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
5/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Septic shock
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Subcutaneous abscess
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
1.6%
7/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urosepsis
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Viral infection
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Cervical vertebral fracture
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Fall
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Incisional hernia
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Peripancreatic fluid collection
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural fistula
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Post procedural inflammation
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Transfusion-related circulatory overload
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
C-reactive protein increased
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram ST segment elevation
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Electrocardiogram repolarisation abnormality
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Liver function test increased
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Transaminases increased
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.9%
8/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour inflammation
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Cerebral infarction
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Syncope
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Product Issues
Device occlusion
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Confusional state
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Delirium
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.70%
3/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Renal failure
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Renal and urinary disorders
Urinary retention
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
5/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Non-cardiogenic pulmonary oedema
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.2%
5/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.2%
5/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Circulatory collapse
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Deep vein thrombosis
|
0.93%
4/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Embolism
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
0.47%
2/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.47%
2/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
1.2%
5/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.71%
3/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.24%
1/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Subclavian vein thrombosis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Thrombophlebitis
|
0.23%
1/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
0.00%
0/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Other adverse events
| Measure |
Nab-Paclitaxel and Gemcitabine
n=429 participants at risk
Participants received nab-Paclitaxel 125 mg/m\^2 administered as an intravenous (IV) infusion over 30 to 40 minutes, followed by gemcitabine 1000 mg/m\^2 as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
Gemcitabine
n=423 participants at risk
Participants received gemcitabine 1000 mg/m\^2 administered as an IV infusion over 30 to 40 minutes on Days 1, 8 and 15 of each 28-day treatment cycle for 6 cycles, unless there was evidence of radiologic disease recurrence, unacceptable toxicity, participant or physician decision, withdrawal of consent, or death.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
41.7%
179/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
33.6%
142/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Leukopenia
|
19.6%
84/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
17.0%
72/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Neutropenia
|
61.3%
263/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
54.4%
230/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
21.9%
94/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.1%
85/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain
|
27.7%
119/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
20.6%
87/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
8.2%
35/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.5%
40/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Constipation
|
26.6%
114/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
21.0%
89/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Diarrhoea
|
56.4%
242/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
29.6%
125/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.9%
21/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
24/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Flatulence
|
5.4%
23/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.4%
27/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Nausea
|
53.8%
231/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
45.4%
192/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Stomatitis
|
18.9%
81/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.7%
24/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Gastrointestinal disorders
Vomiting
|
28.4%
122/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
18.2%
77/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Asthenia
|
22.1%
95/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.6%
49/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Chills
|
8.9%
38/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.4%
23/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Fatigue
|
54.3%
233/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
48.0%
203/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Influenza like illness
|
6.3%
27/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.9%
25/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Oedema peripheral
|
37.8%
162/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
25.5%
108/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Peripheral swelling
|
5.1%
22/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
16/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
General disorders
Pyrexia
|
39.9%
171/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
27.2%
115/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
29/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
20/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Alanine aminotransferase increased
|
9.8%
42/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
33/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Aspartate aminotransferase increased
|
7.2%
31/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.0%
21/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.4%
23/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.0%
17/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Neutrophil count decreased
|
5.4%
23/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.6%
32/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Investigations
Weight decreased
|
12.1%
52/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.2%
22/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
143/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
19.9%
84/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
28/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.9%
8/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
7.9%
34/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.6%
28/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.8%
55/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
5.4%
23/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.9%
68/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.3%
31/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.6%
41/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
10.4%
44/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
5.4%
23/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.5%
15/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
5.8%
25/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
57/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.9%
29/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
45/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
7.8%
33/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dizziness
|
14.9%
64/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
34/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Dysgeusia
|
20.0%
86/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.5%
36/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Headache
|
15.2%
65/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
15.6%
66/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Neuropathy peripheral
|
26.1%
112/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
6.1%
26/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Paraesthesia
|
9.1%
39/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.1%
9/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
33.6%
144/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.8%
16/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Nervous system disorders
Polyneuropathy
|
5.4%
23/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
1.4%
6/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Anxiety
|
7.9%
34/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
9.0%
38/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Psychiatric disorders
Insomnia
|
14.9%
64/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
8.0%
34/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.2%
61/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.1%
51/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
65/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.8%
50/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
17.7%
76/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
3.1%
13/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.5%
28/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.3%
18/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
58.7%
252/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
12.3%
52/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
8.6%
37/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
20/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
49/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
20/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.2%
35/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
4.7%
20/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypertension
|
8.2%
35/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
11.6%
49/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
|
Vascular disorders
Hypotension
|
7.0%
30/429 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
2.8%
12/423 • Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 94 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 46 weeks)
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER