Trial Outcomes & Findings for Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma (NCT NCT03710603)
NCT ID: NCT03710603
Last Updated: 2024-12-24
Results Overview
PFS was defined as duration from date of randomization to either progressive disease (PD)/death whichever occurred first. PD was defined as meeting any one of the following criteria: Increase of \>= 25 % in level of serum M-protein form lowest response value and absolute increase must be \>= 0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24 hours; Only in participants without measurable serum and urine M-protein levels; increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \> 10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
709 participants
Primary outcome timeframe
From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months.
Results posted on
2024-12-24
Participant Flow
Participant milestones
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Overall Study
STARTED
|
354
|
355
|
|
Overall Study
COMPLETED
|
295
|
306
|
|
Overall Study
NOT COMPLETED
|
59
|
49
|
Reasons for withdrawal
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Death
|
44
|
34
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
11
|
10
|
Baseline Characteristics
Daratumumab, VELCADE (Bortezomib), Lenalidomide and Dexamethasone Compared to VELCADE, Lenalidomide and Dexamethasone in Subjects With Previously Untreated Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=354 Participants
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with h bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=355 Participants
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Total
n=709 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.1 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
58.7 years
STANDARD_DEVIATION 7.81 • n=7 Participants
|
58.4 years
STANDARD_DEVIATION 7.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
149 Participants
n=5 Participants
|
144 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
205 Participants
n=5 Participants
|
211 Participants
n=7 Participants
|
416 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
242 Participants
n=7 Participants
|
496 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
80 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
163 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
323 Participants
n=5 Participants
|
330 Participants
n=7 Participants
|
653 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
19 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
82 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
165 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
243 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Switzerland
|
5 participants
n=5 Participants
|
7 participants
n=7 Participants
|
12 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
49 participants
n=5 Participants
|
53 participants
n=7 Participants
|
102 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
27 participants
n=5 Participants
|
32 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
27 participants
n=5 Participants
|
30 participants
n=7 Participants
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Turkey
|
14 participants
n=5 Participants
|
19 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
|
Region of Enrollment
Norway
|
7 participants
n=5 Participants
|
2 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
86 participants
n=5 Participants
|
64 participants
n=7 Participants
|
150 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
38 participants
n=5 Participants
|
34 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Region of Enrollment
France
|
70 participants
n=5 Participants
|
83 participants
n=7 Participants
|
153 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Time Since Initial Diagnosis (months)
|
3 months
STANDARD_DEVIATION 11.41 • n=5 Participants
|
2.2 months
STANDARD_DEVIATION 4.46 • n=7 Participants
|
2.6 months
STANDARD_DEVIATION 8.66 • n=5 Participants
|
|
Stage of Disease (ISS)
I
|
178 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Stage of Disease (ISS)
II
|
125 Participants
n=5 Participants
|
114 Participants
n=7 Participants
|
239 Participants
n=5 Participants
|
|
Stage of Disease (ISS)
III
|
50 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
105 Participants
n=5 Participants
|
|
Stage of Disease (ISS)
unknown
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization to either progressive disease or death whichever occurred first, up to a maximum follow-up time of 54.41 months.Population: Randomized population, intention-to-treat
PFS was defined as duration from date of randomization to either progressive disease (PD)/death whichever occurred first. PD was defined as meeting any one of the following criteria: Increase of \>= 25 % in level of serum M-protein form lowest response value and absolute increase must be \>= 0.5 g/dL; Increase of \>=25% in 24-hour urinary light chain excretion (urine M-protein) from lowest response value and absolute increase must be \>=200 mg/24 hours; Only in participants without measurable serum and urine M-protein levels; increase of \>=25% in difference between involved and uninvolved FLC levels from lowest response value and absolute increase must be \> 10 mg/dL; Definite increase in size of existing bone lesions or soft tissue plasmacytomas; Definite development of new bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL) that can be attributed solely to PC proliferative disorder.
Outcome measures
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=354 Participants
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=355 Participants
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
103 Participants
|
50 Participants
|
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 months.Population: Randomized population, intention-to-treat
Overall MRD-negativity rate was defined as the percentage of participants in the ITT population who achieved both MRD-negativity by NGS (at or below a sensitivity threshold of 10-5) in bone marrow aspirate and a CR or better response at any time after the date of randomization (and prior to disease progression, receipt of subsequent therapy, or both).
Outcome measures
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=354 Participants
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=355 Participants
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Overall MRD Negativity Rate
|
168 Participants
|
267 Participants
|
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants
ORR- percentage of participants who achieved partial response (PR) or better (PR, Very Good Partial Response \[VGPR\], CR or sCR) based on computerized algorithm as per IMWG 2011 criteria. PR -greater than or equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200 mg//24 hours. If serum and urine M-protein are not measurable, a decrease of \>=50% in the difference between involved and uninvolved FLC levels is required. A \>=50% reduction in the size of soft tissue plasmacytomas is also required; VGPR-serum and urine M-component detectable by immunofixation but not on electrophoresis, or \>= 90% reduction in serum M-protein plus urine M-protein \<100 mg/24 hours; CR-negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas, and \<5% PCs in bone marrow. sCR- in addition to CR a normal FLC ratio, and absence of clonal PCs by immunohistochemistry or immunofluorescence or 2 to 4-color flow cytometry.
Outcome measures
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=354 Participants
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=355 Participants
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Percentage of Participants With Overall Response Rate (ORR)
|
93.8 percentage of participants with response
Interval 90.7 to 96.1
|
96.6 percentage of participants with response
Interval 94.2 to 98.2
|
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsPopulation: The intent-to-treat (ITT) population included all randomized participants
Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG 2011 criteria for CR: Negative immunofixation on the serum and urine, and disappearance of any soft tissue plasmacytomas (PCs), and \<5% PCs in bone marrow; sCR: CR and normal FLC ratio, absence of clonal PCs by immunohistochemistry, immunofluorescence or 2 to 4 color flow cytometry.
Outcome measures
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=354 Participants
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=355 Participants
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Percentage of Participants With Overall Complete Response (CR) or Better
|
70.1 percentage of participants with response
Interval 65.0 to 74.8
|
87.9 percentage of participants with response
Interval 84.0 to 91.1
|
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsProgression-free survival on the next line of therapy (PFS2) is defined as the time from randomization to progression on the next line of treatment or death, whichever comes first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsOverall Survival (OS), measured from the date of from randomization to the date the subject's death
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsTime to response (PR or better), time to CR/sCR are defined as the time from randomization to date of initial response (or initial CR/sCR)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsDuration of response (PR or better), duration of CR, duration of sCR, and duration of MRD-negative status, are calculated from the date of the initial documentation of a response (PR or better), or CR or better, or sCR, or MRD-negative status to the date of the first documented evidence of disease progression, as defined in the IMWG criteria, whichever occurs first.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsPharmacokinetic concentrations of daratumumab
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsImmunogenicity of daratumumab serum samples will be screened for antibodies binding to daratumumab and serum titer will also be determined from confirmed positive samples using validated immunoassay methods. Other immunogenicity analyses (eg, assessment of neutralizing capabilities) may be performed to further characterize the immune responses that are generated. Plasma samples will be screened for antibodies binding to rHuPH20 and will be assessed in confirmatory and titer assays as necessary
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsThe EORTC QLQ-C30 is a 30-item questionnaire containing both single and multi-item measures. These include five functional scales (Physical, Role, Cognitive, Emotional, and Social Functioning), three symptom scales (Fatigue, Pain, and Nausea/Vomiting), a Global Health Status/ Quality-of-Life (QoL) scale, and six single items (Constipation, Diarrhea, Insomnia, Dyspnea, Appetite Loss, and Financial Difficulties). The scores ranges from 0-100, a high score for functional scales and for Global Health Status/QoL represent better functioning ability or Health-Related Quality-of-Life (HRQoL), whereas a high score for symptom scales and single items represents significant symptomatology.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsThe EORTC QLQ-MY20 is a supplement to the QLQ-C30 instrument used in subjects with MY. The module comprises 20 questions that address four myeloma-specific HRQoL domains: Disease Symptoms, Side Effects of Treatment, Future Perspective, and Body Image. A high score for Disease Symptoms and Side Effects of Treatment represents a high level of symptomatology or problems, whereas a high score for Future Perspective and Body Image represents better outcomes.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date. Maximum follow up was 54.41 monthsThe EQ-5D-5L is a 5 item questionnaire that assesses 5 domains including mobility, self care, usual activities, pain/discomfort, and anxiety/depression plus a visual analog scale rating "health today"
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date.Median CD34+ cell yield
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From randomization to the clinical cutoff date.Time to engraftment post-ASCT defined as absolute neutrophil count (ANC) ≥0.5 x 109/L and platelet count ≥20 x 109/L
Outcome measures
Outcome data not reported
Adverse Events
Velcade Lenalidomide Dexamethasone (VRd)
Serious events: 171 serious events
Other events: 341 other events
Deaths: 44 deaths
Daratumumab + VRd (D-VRd)
Serious events: 200 serious events
Other events: 348 other events
Deaths: 34 deaths
Serious adverse events
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=347 participants at risk
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=351 participants at risk
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Febrile Bone Marrow Aplasia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
4.6%
16/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
4.6%
16/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Immune Thrombocytopenia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Thrombotic Microangiopathy
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Atrial Fibrillation
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.6%
9/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Atrial Flutter
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Cardiac Amyloidosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Cardiac Arrest
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Cardiac Failure
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Left Ventricular Dysfunction
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Myocardial Infarction
|
1.2%
4/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Pericardial Effusion
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Cardiac disorders
Ventricular Tachycardia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Congenital, familial and genetic disorders
Atrial Septal Defect
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Endocrine disorders
Hypothyroidism
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Endocrine disorders
Inappropriate Antidiuretic Hormone Secretion
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Eye disorders
Dacryostenosis Acquired
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Eye disorders
Diplopia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Eye disorders
Retinal Detachment
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Eye disorders
Vision Blurred
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Abdominal Pain Lower
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Anal Fistula
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Colitis
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Constipation
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Diarrhoea
|
2.6%
9/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.0%
7/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Diverticular Perforation
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Gastric Ulcer Haemorrhage
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Gingival Bleeding
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Neutropenic Colitis
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Obstructive Pancreatitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Pancreatitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Proctitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Rectal Ulcer Haemorrhage
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Asthenia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Chest Pain
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Chills
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Death
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Fatigue
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Gait Disturbance
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Influenza Like Illness
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Non-Cardiac Chest Pain
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Pain
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Pyrexia
|
4.6%
16/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
3.7%
13/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Systemic Inflammatory Response Syndrome
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Biliary Dilatation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Biliary Obstruction
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Cholecystitis
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Hepatic Cytolysis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Hepatobiliary disorders
Non-Alcoholic Steatohepatitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Immune system disorders
Hypersensitivity
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Abdominal Abscess
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Abscess Neck
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Acute Sinusitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Anal Abscess
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Appendicitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Appendicitis Perforated
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Bacteraemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Bacterial Diarrhoea
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Biliary Tract Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Bronchitis
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Bronchopulmonary Aspergillosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Campylobacter Gastroenteritis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Campylobacter Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Chorioretinitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Citrobacter Infection
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Covid-19
|
1.7%
6/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
3.7%
13/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Covid-19 Pneumonia
|
1.4%
5/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
3.1%
11/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Cytomegalovirus Enteritis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Cytomegalovirus Enterocolitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Cytomegalovirus Infection Reactivation
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Device Related Infection
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Diverticulitis
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Enterocolitis Viral
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Erysipelas
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Escherichia Bacteraemia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Escherichia Peritonitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Escherichia Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Escherichia Urinary Tract Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Gastroenteritis Escherichia Coli
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Gastroenteritis Salmonella
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
H1n1 Influenza
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Haemorrhoid Infection
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Hcov-Oc43 Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Hepatitis B Reactivation
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Herpes Zoster
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Herpes Zoster Reactivation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Infestation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Influenza
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Klebsiella Infection
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Klebsiella Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Large Intestine Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Listeria Sepsis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.6%
9/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Lower Respiratory Tract Infection Bacterial
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Meningitis Cryptococcal
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Meningitis Listeria
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Mucormycosis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Neutropenic Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Osteomyelitis Salmonella
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Parainfluenzae Virus Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Perirectal Abscess
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pilonidal Disease
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumocystis Jirovecii Pneumonia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia
|
6.1%
21/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
11.4%
40/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Bacterial
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Cytomegaloviral
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Haemophilus
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Influenzal
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Legionella
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
1.4%
5/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Parainfluenzae Viral
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Pneumococcal
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Respiratory Syncytial Viral
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Streptococcal
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Post Procedural Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pseudomonal Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pseudomonas Infection
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pyelonephritis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Respiratory Syncytial Virus Bronchitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Respiratory Tract Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Rhinovirus Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Salmonella Bacteraemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Sepsis
|
2.6%
9/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.0%
7/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Septic Shock
|
1.2%
4/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Sinusitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Staphylococcal Abscess
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Staphylococcal Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Streptococcal Bacteraemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Subcutaneous Abscess
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.3%
8/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.0%
7/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Urinary Tract Infection
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
1.4%
5/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Urosepsis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Varicella Zoster Virus Infection
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Viral Infection
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Wound Infection
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Accident
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Fall
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Humerus Fracture
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Lumbar Vertebral Fracture
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Post Procedural Fever
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Post Procedural Haematoma
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Procedural Vomiting
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Surgical Skin Tear
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Electrocardiogram Abnormal
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Weight Decreased
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Diabetic Metabolic Decompensation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Gout
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Greater Trochanteric Pain Syndrome
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Soft Tissue Necrosis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Vertebral Lesion
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Erythroid Leukaemia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Lymphocytic Leukaemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute Myeloid Leukaemia
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of Colon
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angioimmunoblastic T-Cell Lymphoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Neoplasm
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Adenocarcinoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo Maligna
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Melanoma
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic Syndrome
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
1.1%
4/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myxofibrosarcoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Adenoma
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma of Skin
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Transitional Cell Carcinoma
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Aphasia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Brain Oedema
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Brain Stem Stroke
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Chronic Inflammatory Demyelinating Polyradiculoneuropathy
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Dysaesthesia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Facial Paralysis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Intensive Care Unit Acquired Weakness
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Myelopathy
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Peripheral Sensorimotor Neuropathy
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Presyncope
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Subarachnoid Haemorrhage
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Syncope
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
1.1%
4/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Vith Nerve Paralysis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Confusional State
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Mania
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Psychiatric Decompensation
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Psychotic Disorder
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Substance-Induced Psychotic Disorder
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Renal and urinary disorders
Bladder Disorder
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Renal and urinary disorders
Nephrotic Syndrome
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Renal and urinary disorders
Renal Impairment
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Renal and urinary disorders
Renal Injury
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Reproductive system and breast disorders
Breast Disorder
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Reproductive system and breast disorders
Cystocele
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Reproductive system and breast disorders
Vaginal Fistula
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Failure
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.85%
3/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.4%
5/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
2.6%
9/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Dermatitis Exfoliative Generalised
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Drug Reaction with Eosinophilia and Systemic Symptoms
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Erythrodermic Atopic Dermatitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson Syndrome
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.86%
3/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Embolism
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Haematoma
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Hypotension
|
0.58%
2/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.57%
2/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Orthostatic Hypotension
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
1.1%
4/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Phlebitis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Subclavian Vein Thrombosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Thrombosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Vasculitis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Vena Cava Thrombosis
|
0.29%
1/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.00%
0/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Venous Thrombosis
|
0.00%
0/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
0.28%
1/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
Other adverse events
| Measure |
Velcade Lenalidomide Dexamethasone (VRd)
n=347 participants at risk
Arm A: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
Daratumumab + VRd (D-VRd)
n=351 participants at risk
Arm B: Patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation were treated with subcutaneous daratumumab in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation followed by subcutaneous daratumumab in combination with lenalidomide maintenance in 28-day cycles. After 4 cycles of induction, patients received high dose therapy with autologous stem cell transplantation.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
20.7%
72/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
21.9%
77/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.3%
22/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.4%
19/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Leukopenia
|
4.0%
14/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.8%
31/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.6%
9/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.7%
20/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Neutropenia
|
58.8%
204/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
68.7%
241/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
34.3%
119/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
48.4%
170/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Abdominal Pain
|
10.7%
37/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.8%
31/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
6.3%
22/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
9.4%
33/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Constipation
|
34.0%
118/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
33.6%
118/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Diarrhoea
|
53.3%
185/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
60.7%
213/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Dyspepsia
|
6.9%
24/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.5%
30/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Nausea
|
16.7%
58/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
19.9%
70/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Stomatitis
|
8.6%
30/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.5%
30/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Gastrointestinal disorders
Vomiting
|
7.8%
27/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
10.8%
38/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Asthenia
|
25.6%
89/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
26.8%
94/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Fatigue
|
26.2%
91/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
23.9%
84/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Influenza Like Illness
|
9.2%
32/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
11.1%
39/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Oedema Peripheral
|
21.3%
74/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
20.5%
72/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
General disorders
Pyrexia
|
30.0%
104/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
29.1%
102/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Immune system disorders
Hypogammaglobulinaemia
|
2.0%
7/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.0%
28/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Bronchitis
|
10.7%
37/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
18.8%
66/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Covid-19
|
22.2%
77/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
32.8%
115/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Gastroenteritis
|
3.7%
13/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.7%
20/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Herpes Zoster
|
6.3%
22/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
4.8%
17/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Influenza
|
6.6%
23/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.7%
20/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
4.3%
15/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.4%
19/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Nasopharyngitis
|
11.2%
39/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
16.5%
58/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Pneumonia
|
6.1%
21/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.3%
29/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
23.6%
82/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
30.5%
107/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Infections and infestations
Urinary Tract Infection
|
7.5%
26/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.8%
31/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Alanine Aminotransferase Increased
|
14.7%
51/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
16.2%
57/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Aspartate Aminotransferase Increased
|
8.4%
29/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.0%
28/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
7.5%
26/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.1%
18/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
7.8%
27/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.4%
19/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
6.3%
22/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.5%
30/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
4.3%
15/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.1%
18/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
7.8%
27/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
6.8%
24/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
12.4%
43/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
14.2%
50/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.9%
69/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
17.7%
62/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
18.7%
65/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
22.2%
78/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
8.4%
29/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.3%
29/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
16.1%
56/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
19.1%
67/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
4.6%
16/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
6.3%
22/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.8%
20/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.3%
29/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
10.7%
37/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
11.4%
40/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Dizziness
|
9.8%
34/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
7.7%
27/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Dysgeusia
|
4.6%
16/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
6.8%
24/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Headache
|
10.7%
37/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.8%
31/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Neuralgia
|
8.6%
30/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
10.0%
35/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Paraesthesia
|
12.1%
42/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
13.1%
46/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
51.6%
179/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
53.6%
188/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Nervous system disorders
Tremor
|
5.2%
18/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
7.7%
27/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Anxiety
|
5.2%
18/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
5.1%
18/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Psychiatric disorders
Insomnia
|
17.6%
61/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
27.1%
95/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.7%
51/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
24.2%
85/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.6%
23/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
10.5%
37/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.1%
21/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
4.3%
15/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
3.7%
13/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
6.0%
21/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.2%
18/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
7.7%
27/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.6%
16/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
7.4%
26/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Rash
|
27.1%
94/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
23.4%
82/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-Papular
|
7.8%
27/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
7.4%
26/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Hypertension
|
6.1%
21/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
8.5%
30/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
|
Vascular disorders
Hypotension
|
4.0%
14/347 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
6.3%
22/351 • AEs that started during the treatment until 30 days after the last dose of study treatment. Maximum follow up was 54.41 months.
All-cause mortality is reported for all participants enrolled/randomized in the study (Intent-to-treat population). Serious adverse events and other adverse events are reported for all participants who received at least one dose of study treatment (Safety population).
|
Additional Information
Sarah Lonergan
Stichting European Myeloma Network (EMN)
Phone: +31 10 268 70 65
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place