Trial Outcomes & Findings for Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM (NCT NCT03481556)
NCT ID: NCT03481556
Last Updated: 2022-12-19
Results Overview
Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B: * Grade 3 non-hematologic toxicity preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle. * Grade 4 or greater non-hematologic toxicity. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm\^3) preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle or with clinically significant bleeding during the 1st cycle. * Grade 4 neutropenia (ANC \< 500 cells/mm\^3), lasting more than 7 days during the 1st cycle. * Greater than 14 days' delay to meet the criteria for the start of a new cycle (Cycle 2) due to toxicity.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Cycle 1: Day 1 to Day 28
Results posted on
2022-12-19
Participant Flow
56 participants were enrolled across 13 sites in the Czech Republic, France, Spain and the United States.
A total of 56 participants were enrolled in the study, all of whom received study treatment.
Participant milestones
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
8
|
6
|
27
|
|
Overall Study
COMPLETED
|
0
|
1
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
15
|
7
|
5
|
25
|
Reasons for withdrawal
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with subcutaneous (SQ) bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone orally (PO) at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
Participants were administered intravenous (IV) melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
0
|
0
|
|
Overall Study
Death
|
4
|
2
|
3
|
16
|
|
Overall Study
Study Terminated by Sponsor
|
10
|
5
|
2
|
9
|
Baseline Characteristics
Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM
Baseline characteristics by cohort
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.7 years
STANDARD_DEVIATION 8.17 • n=5 Participants
|
69.4 years
STANDARD_DEVIATION 5.13 • n=7 Participants
|
60.5 years
STANDARD_DEVIATION 12.13 • n=5 Participants
|
62.3 years
STANDARD_DEVIATION 11.15 • n=4 Participants
|
65.1 years
STANDARD_DEVIATION 10.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 to Day 28Population: Only participants included in the DLT Analysis set were included in this analysis. The DLT Analysis Set was defined as all participants in Phase 1 that complete Cycle 1 of therapy or are discontinued due to a DLT event.
Toxicity was graded according to the National Cancer Institute - Common Terminology Criteria for Adverse Events Version 4.03. DLT criteria that apply to Regimens A and B: * Grade 3 non-hematologic toxicity preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle. * Grade 4 or greater non-hematologic toxicity. * Grade 4 thrombocytopenia (platelet count \< 25,000 cells/ mm\^3) preventing the administration of \> 1 dose of bortezomib or daratumumab during the 1st cycle or with clinically significant bleeding during the 1st cycle. * Grade 4 neutropenia (ANC \< 500 cells/mm\^3), lasting more than 7 days during the 1st cycle. * Greater than 14 days' delay to meet the criteria for the start of a new cycle (Cycle 2) due to toxicity.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=3 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Phase 1: Number of Participants Who Experienced a Dose Limiting Toxicity (DLT)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set were included in this analysis.
ORR was defined as the percentage of participants who achieved a best confirmed response of Partial Response (PR) or better.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Phase 2: Overall Response Rate (ORR)
|
80 percentage of participants
Interval 51.9 to 95.7
|
75 percentage of participants
Interval 34.9 to 96.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
70.4 percentage of participants
Interval 49.8 to 86.2
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set were included in this analysis.
BR defined by International Myeloma Working Group Uniform Response Criteria. BR= Complete Response (CR)/Stringent CR (sCR) defined as below negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow/plus normal free light chain (FLC) ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence, Very Good Partial Response (VGPR)= serum and urine M-protein detectable by immunofixation but not on electrophoresis or \> 90% reduction in serum M-protein plus urine M-protein level \< 100 mg/24 hours, Partial Response (PR)= a \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \> 90% or to \< 200 mg/24 hours, Minimal Response (MR), Stable Disease (SD)= not meeting the criteria for other response options, Progressive Disease (PD)= increase of \> 25% from lowest response value in serum/urine M-component or bone marrow plasma cell percentage, or non-evaluable.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Best Response (BR)
CR
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Best Response (BR)
sCR
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (BR)
SD
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Best Response (BR)
VGPR
|
2 Participants
|
3 Participants
|
2 Participants
|
6 Participants
|
|
Best Response (BR)
PR
|
9 Participants
|
2 Participants
|
2 Participants
|
11 Participants
|
|
Best Response (BR)
MR
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (BR)
PD
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Best Response (BR)
Non-evaluable
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Best Response (BR)
Missing
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.
DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=12 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=5 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=19 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Duration of Response (DOR)
|
9.0 months
Interval 4.9 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
NA months
Median and confidence interval values could not be calculated as the fraction of participants experiencing events was too low.
|
24.2 months
Interval 10.6 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
9.9 months
Interval 7.2 to 14.8
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.
Time from Cycle 1 Day 1 to a response of PR or better.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=12 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=5 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=19 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Time to Response (TTR)
|
3.0 months
Interval 1.0 to 8.6
|
2.2 months
Interval 1.0 to 4.6
|
3.3 months
Interval 1.0 to 4.2
|
1.1 months
Interval 0.9 to 5.3
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set were included in this analysis.
PFS was defined as the time in months from date of initiation of therapy to the earlier of confirmed disease progression or death due to any cause.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Progression-Free Survival (PFS)
|
10.0 months
Interval 7.5 to 33.5
|
24.30 months
Interval 2.9 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
28.4 months
Interval 14.3 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
9.7 months
Interval 6.7 to 14.2
|
SECONDARY outcome
Timeframe: Up to 24 months following confirmed disease progression, or initiation of subsequent therapy (a maximum of 198.9 weeks)Population: Only participants included in the Safety Analysis Set were included in this analysis.
Time from the first dose of melflufen to death due to any cause.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Overall Survival (OS)
|
33.5 months
Interval 9.0 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
NA months
Median and confidence interval values could not be calculated as the fraction of participants experiencing events was too low.
|
35.0 months
Interval 6.4 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
18.3 months
Interval 14.29 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set with a confirmed MR or better were included in this analysis.
DOCB was defined as time in months from the first evidence of confirmed assessment of sCR, CR, VGPR, PR or MR to first confirmed disease progression, or to death due to any cause.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=13 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=5 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=20 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Duration of Clinical Benefit (DOCB)
|
15.7 months
Interval 7.6 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
21.3 months
Interval 13.7 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
27.20 months
Interval 13.1 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
10.9 months
Interval 8.4 to 14.5
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants in the Safety Analysis Set are included in this analysis.
TTP defined as time from first dose to first documented confirmed progression.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Time to Progression (TTP)
|
17.6 months
Interval 7.5 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
24.3 months
Interval 2.9 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
29.2 months
Interval 14.3 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
11.5 months
Interval 7.7 to 15.4
|
SECONDARY outcome
Timeframe: Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set were included in this analysis.
≥ Minimal response for participants included sCR, CR, VGPR, PR and MR.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Clinical Benefit Rate (≥ Minimal Response)
|
86.7 percentage of participants
Interval 59.5 to 98.3
|
75.0 percentage of participants
Interval 34.9 to 96.8
|
83.3 percentage of participants
Interval 35.9 to 99.6
|
74.1 percentage of participants
Interval 53.7 to 88.9
|
SECONDARY outcome
Timeframe: Until death or initiation of subsequent therapy (a maximum of 194.3 weeks)Population: All participants included in the Safety Analysis Set were included in this analysis.
Defined as time from date of initiation of therapy to start of next line of therapy.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Time to Next Treatment (TTNT)
|
33.50 months
Interval 9.0 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
14.70 months
Interval 3.9 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
26.25 months
Interval 2.3 to
Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
|
9.5 months
Interval 5.6 to 13.4
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 up to a maximum of 198.9 weeksPopulation: Only participants included in the Safety Analysis Set were included in this analysis.
TEAEs were defined as adverse events (AEs) that started after the first dose of study medication was administered and within 30 days of the last administration of the study treatment or before start of subsequent anticancer treatment (whichever occurred first) or that worsened after the first dose of study medication was administered.
Outcome measures
| Measure |
Regimen A - Melflufen 30mg + Bortezomib + Dexamethasone
n=15 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen A - Melflufen 40mg + Bortezomib + Dexamethasone
n=8 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
Regimen B - Melflufen 30mg + Daratumumab + Dexamethasone
n=6 Participants
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
Regimen B - Melflufen 40mg + Daratumumab + Dexamethasone
n=27 Participants
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Any TEAEs
|
15 Participants
|
8 Participants
|
6 Participants
|
27 Participants
|
|
Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Any Grade 3 or Higher TEAEs
|
15 Participants
|
8 Participants
|
6 Participants
|
26 Participants
|
Adverse Events
A (Melflufen+Bortezomib+Dex) 30 mg
Serious events: 9 serious events
Other events: 15 other events
Deaths: 4 deaths
A (Melflufen+Bortezomib+Dex) 40 mg
Serious events: 5 serious events
Other events: 8 other events
Deaths: 2 deaths
B (Melflufen+Daratumumab+Dex) 30 mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 3 deaths
B (Melflufen+Daratumumab+Dex) 40 mg
Serious events: 11 serious events
Other events: 27 other events
Deaths: 16 deaths
Serious adverse events
| Measure |
A (Melflufen+Bortezomib+Dex) 30 mg
n=15 participants at risk
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
A (Melflufen+Bortezomib+Dex) 40 mg
n=8 participants at risk
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
B (Melflufen+Daratumumab+Dex) 30 mg
n=6 participants at risk
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
B (Melflufen+Daratumumab+Dex) 40 mg
n=27 participants at risk
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
COVID-19 pneumonia
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Sepsis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Atypical pneumonia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Pneumonia pneumococcal
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Vascular device infection
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Pneumoperitoneum
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Cardiac failure chronic
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Right ventricular hypertrophy
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Facial paresis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Diffuse large B-cell lymphoma
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Renal and urinary disorders
Calculus urinary
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Deep vein thrombosis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
Other adverse events
| Measure |
A (Melflufen+Bortezomib+Dex) 30 mg
n=15 participants at risk
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
A (Melflufen+Bortezomib+Dex) 40 mg
n=8 participants at risk
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
|
B (Melflufen+Daratumumab+Dex) 30 mg
n=6 participants at risk
Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
B (Melflufen+Daratumumab+Dex) 40 mg
n=27 participants at risk
Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone PO at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
|
|---|---|---|---|---|
|
General disorders
Fatigue
|
33.3%
5/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
40.7%
11/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Asthenia
|
26.7%
4/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.9%
7/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Pyrexia
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
22.2%
6/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Oedema peripheral
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Chills
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
86.7%
13/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
100.0%
8/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
100.0%
6/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
63.0%
17/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
73.3%
11/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
87.5%
7/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
100.0%
6/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
63.0%
17/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
10/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
75.0%
6/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
83.3%
5/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
59.3%
16/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
5/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
9/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Nausea
|
26.7%
4/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.9%
7/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
18.5%
5/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
14.8%
4/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
26.7%
4/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
66.7%
4/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
22.2%
6/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Urinary tract infection
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
50.0%
3/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Infection
|
26.7%
4/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
37.5%
3/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
50.0%
3/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Influenza
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Lower respiratory tract infection
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Nasopharyngitis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
50.0%
3/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Erythema migrans
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
COVID-19
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
37.5%
3/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Platelet count decreased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
22.2%
6/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Weight decreased
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
C-reactive protein increased
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
SARS-CoV-2 test positive
|
26.7%
4/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
18.5%
5/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
14.8%
4/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
14.8%
4/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
22.2%
6/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Fall
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
33.3%
2/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
14.8%
4/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
50.0%
3/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
11.1%
3/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
25.0%
2/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Polyneuropathy
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
22.2%
6/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Psychiatric disorders
Depression
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Hypotension
|
20.0%
3/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Haemorrhage
|
13.3%
2/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Ear and labyrinth disorders
Vertigo
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Product Issues
Device dislocation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Blood and lymphatic system disorders
Hypoprothrombinaemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Discomfort
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
General physical health deterioration
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Influenza like illness
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Oedema
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Peripheral swelling
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
General disorders
Withdrawal syndrome
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Device related infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Herpes zoster
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Tooth infection
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Asymptomatic COVID-19
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Bacteriuria
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Campylobacter infection
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Carbuncle
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Cellulitis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Furuncle
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Gastroenteritis clostridal
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Herpes zoster oticus
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Periodonitis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Post-acute COVID-19 syndrome
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Pustule
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Vascular device infection
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Viral infection
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Enteritis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Gastrointestinal motility disorder
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Haematochezia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Hiatus hernia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Gamm-glutamyltransferase decreased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
Weight increased
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Investigations
White blood cell count decreased
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Fluid retention
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteolysis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Scleroderma
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Neuralgia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Post herpetic neuralgia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Nervous system disorders
Transient ischaemic attack
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Skin toxicity
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Embolism
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Hot flush
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
7.4%
2/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Cardiac disorders
Supraventricular tachycardia
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Eye disorders
Vision blurred
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Eye disorders
Eye oedema
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
3.7%
1/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Eye disorders
Scleral haemorrhage
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Renal and urinary disorders
Haematuria
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
16.7%
1/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
12.5%
1/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Hepatobiliary disorders
Liver disorder
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Reproductive system and breast disorders
Cystocele
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
|
Infections and infestations
Periodontitis
|
6.7%
1/15 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/8 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/6 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
0.00%
0/27 • Cycle 1 Day 1 up to a maximum of 198.9 weeks
All AEs that were spontaneously reported by the participant or detected during or between visits by non-directive questioning, through physical examination, laboratory test, or other assessments were reported in the eCRF. All participants included in the Safety Analysis Set were included in this analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place