Trial Outcomes & Findings for Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma (NCT NCT01615029)
NCT ID: NCT01615029
Last Updated: 2026-01-12
Results Overview
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
45 participants
Primary outcome timeframe
Up to 3 years
Results posted on
2026-01-12
Participant Flow
Participant milestones
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
4
|
3
|
32
|
|
Overall Study
COMPLETED
|
1
|
2
|
0
|
2
|
16
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
4
|
1
|
16
|
Reasons for withdrawal
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
0
|
3
|
0
|
4
|
|
Overall Study
Progressive disease
|
1
|
1
|
1
|
1
|
10
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
0
|
2
|
Baseline Characteristics
Daratumumab in Combination With Lenalidomide and Dexamethasone in Relapsed and Relapsed-refractory Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=4 Participants
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 Participants
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.7 Years
STANDARD_DEVIATION 12.74 • n=210 Participants
|
62.7 Years
STANDARD_DEVIATION 2.08 • n=19 Participants
|
57.5 Years
STANDARD_DEVIATION 9.68 • n=8 Participants
|
67.3 Years
STANDARD_DEVIATION 10.26 • n=24 Participants
|
59.7 Years
STANDARD_DEVIATION 8.38 • n=5716 Participants
|
60.4 Years
STANDARD_DEVIATION 8.57 • n=47026 Participants
|
|
Sex/Gender, Customized
Male
|
3 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
22 Participants
n=5716 Participants
|
32 Participants
n=47026 Participants
|
|
Sex/Gender, Customized
Female
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=5716 Participants
|
13 Participants
n=47026 Participants
|
|
Region of Enrollment
Denmark
|
2 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
5 Participants
n=5716 Participants
|
11 Participants
n=47026 Participants
|
|
Region of Enrollment
France
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=5716 Participants
|
7 Participants
n=47026 Participants
|
|
Region of Enrollment
Italy
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
8 Participants
n=5716 Participants
|
8 Participants
n=47026 Participants
|
|
Region of Enrollment
Netherlands
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
6 Participants
n=5716 Participants
|
9 Participants
n=47026 Participants
|
|
Region of Enrollment
United Kingdom
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
4 Participants
n=5716 Participants
|
7 Participants
n=47026 Participants
|
|
Region of Enrollment
United States
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=5716 Participants
|
3 Participants
n=47026 Participants
|
|
Stage of Disease [International Staging System (ISS)
Stage I
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
15 Participants
n=5716 Participants
|
21 Participants
n=47026 Participants
|
|
Stage of Disease [International Staging System (ISS)
Stage II
|
2 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
14 Participants
n=5716 Participants
|
18 Participants
n=47026 Participants
|
|
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory drug (IMiD)
Both a PI and IMiD
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
3 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
4 Participants
n=47026 Participants
|
|
Stage of Disease [International Staging System (ISS)
Stage III
|
1 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=5716 Participants
|
6 Participants
n=47026 Participants
|
|
Number of Prior Lines of Therapy
1 Line
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
15 Participants
n=5716 Participants
|
15 Participants
n=47026 Participants
|
|
Number of Prior Lines of Therapy
2-3 Lines
|
2 Participants
n=210 Participants
|
3 Participants
n=19 Participants
|
3 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
17 Participants
n=5716 Participants
|
27 Participants
n=47026 Participants
|
|
Number of Prior Lines of Therapy
>3 Lines
|
1 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=5716 Participants
|
3 Participants
n=47026 Participants
|
|
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory drug (IMiD)
PI only
|
0 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
5 Participants
n=5716 Participants
|
7 Participants
n=47026 Participants
|
|
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory drug (IMiD)
IMiD only
|
0 Participants
n=210 Participants
|
1 Participants
n=19 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=5716 Participants
|
3 Participants
n=47026 Participants
|
|
Refractory to Proteasome Inhibitor (PI)/ Immunomodulatory drug (IMiD)
None
|
3 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
26 Participants
n=5716 Participants
|
31 Participants
n=47026 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1.
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). International Myeloma Working Group (IMWG) criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immuno fluorescence; PR: greater than equal to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=4 Participants
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
n=13 Participants
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 1: Percentage of Participants With Overall Response Rate (ORR)
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
100.0 Percentage of participants
Interval 29.2 to 100.0
|
75.0 Percentage of participants
Interval 19.4 to 99.4
|
66.7 Percentage of participants
Interval 9.4 to 99.2
|
85.4 Percentage of participants
Interval 64.8 to 98.1
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-Treat (ITT) population analysis set included all enrolled participants who signed the informed consent during Phase 2.
ORR is defined as percentage of participants who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR). IMWG criteria (2011)- CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and less than (\<) 5 percentage (%) plasma cells in bone marrow; sCR: CR+Normal free light chain ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence; PR: greater than eqaul to (\>=) 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>= 90 percentage (%) or to \<200 mg/24 hours; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100 mg per 24 hour.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Percentage of Participants With Overall Response Rate (ORR)
|
81.3 Percentage of participants
Interval 63.6 to 92.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Responders in Intent-to-Treat (ITT) population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Duration of response was calculated from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the IMWG criteria (2011).
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=26 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Duration of Response
|
NA Months
Interval 26.5 to
Median and the upper bound of the 95% confidence interval (CI) were not estimable due to insufficient number of participants and/or events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: Responders in all treated population analysis set included. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 Participants
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=2 Participants
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 1: Time to Response
Time to first response
|
0.99 Months
Interval 0.5 to 1.0
|
1.02 Months
Interval 0.5 to 1.9
|
1.02 Months
Interval 1.0 to 1.8
|
2.25 Months
Interval 1.9 to 2.6
|
—
|
|
Phase 1: Time to Response
Time to best response
|
1.9 Months
Interval 1.0 to 6.5
|
13.17 Months
Interval 3.7 to 20.7
|
8.41 Months
Interval 1.0 to 19.9
|
16.72 Months
Interval 6.5 to 26.9
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2. Here, 'N' (overall number of participants analyzed) signifies participants evaluable for this outcome measure.
Time to first response was defined as the time from the date of first dose of daratumumab to the date of initial documentation of a response (PR or better). Time to best response was defined as the time between the date of first dose of daratumumab and the date of the initial evaluation of the best response (PR or better) to treatment.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=26 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Time to Response
Time to first response
|
0.99 Months
Interval 0.5 to 5.6
|
—
|
—
|
—
|
—
|
|
Phase 2: Time to Response
Time to best response
|
6.95 Months
Interval 0.5 to 26.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
TTP was defined as the number of days from the date of first infusion (Day 1) to the date of first record of disease progression. Disease progression (IMWG criteria 2011): increase of \>=25 percent (%) from lowest response level in Serum M-component and/or (the absolute increase must be \>=0.5 g/dL) Urine M-component and/or (the absolute increase must be \>=200 mg/24 hour; only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved free light chain levels. The absolute increase must be \>10 mg/dL; Bone marrow plasma cell percentage: the absolute % must be \>=10 %; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder. Median TTP was estimated by using the Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Time to Progression (TTP)
|
NA Months
Interval 27.0 to
Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Progression free survival (PFS) was defined as the time between the date of first dose of daratumumab and either disease progression or death, whichever occurs first.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Progression-Free Survival (PFS)
|
NA Months
Interval 16.62 to
Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 5 yearsPopulation: ITT population analysis set included all enrolled participants who signed the informed consent during Phase 2.
Overall Survival (OS) was defined as the number of days from administration of the first infusion (Day 1) to date of death. Median Overall Survival was estimated by using the Kaplan Meier method.
Outcome measures
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 Participants
Participants administered with daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: Daratumumab (2-16 mg/kg) + Lenalidomide and Dexamethasone
Participants were administered Daratumumab at escalating doses of 2 mg/kg, 4 mg/kg, 8 mg/kg, or 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Day 1 of Cycles 3 to 6, and Day 1 of Cycles 7 and beyond. Each cycle consisted of 28 days. Lenalidomide (25 mg was administered orally once daily on Days 1 to 21 of each 28-day cycle) and Dexamethasone (40 mg weekly) were administered concurrently. Dexamethasone dosage could be reduced to 20 mg weekly after Cycle 6 or at the investigator's discretion. Each treatment cycle consisted of 28 days.
|
|---|---|---|---|---|---|
|
Phase 2: Overall Survival (OS)
|
NA Months
Interval 32.23 to
Median and the upper bound of the 95% CI were not estimable due to insufficient number of participants and/or events.
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
Serious events: 3 serious events
Other events: 4 other events
Deaths: 1 deaths
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
Serious events: 22 serious events
Other events: 31 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants received daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=4 participants at risk
Participants received with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 participants at risk
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Endocrine disorders
Steroid Withdrawal Syndrome
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Retinal Artery Thrombosis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Pyrexia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Sudden Death
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Influenza
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Pneumonia Viral
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Septic Shock
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Spinal Fracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Influenza A Virus Test Positive
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma Gastric
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Epstein-Barr Virus Associated Lymphoma
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Cerebral Infarction
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
Other adverse events
| Measure |
Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants received daratumumab 2 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=4 participants at risk
Participants received with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (cycles 3 to 6), Day 1 (cycle 7+) along with lenalidomide 25 mg on Day 1 to 21 of each 28-day cycle and dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=3 participants at risk
Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone
n=32 participants at risk
Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator's discretion). Each treatment cycle consists of 28 days.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
15.6%
5/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Neutropenia
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
4/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
90.6%
29/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
34.4%
11/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Cardiac disorders
Atrial Fibrillation
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Cardiac disorders
Bradycardia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Cardiac disorders
Palpitations
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Cardiac disorders
Supraventricular Tachycardia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Endocrine disorders
Pituitary-Dependent Cushing's Syndrome
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Endocrine disorders
Steroid Withdrawal Syndrome
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Glaucoma
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Lacrimation Increased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Retinal Artery Thrombosis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Visual Impairment
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Eye disorders
Vitreous Detachment
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Constipation
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
21.9%
7/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Diarrhoea
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
75.0%
3/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
56.2%
18/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Hypoaesthesia Oral
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Mouth Ulceration
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
34.4%
11/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Tongue Blistering
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Toothache
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
15.6%
5/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Application Site Erythema
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Asthenia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Chest Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Facial Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Fatigue
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
4/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
40.6%
13/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Inflammation
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Influenza Like Illness
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Oedema
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Oedema Peripheral
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Peripheral Swelling
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
28.1%
9/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Immune system disorders
Immune System Disorder
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
28.1%
9/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Cystitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Diarrhoea Infectious
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Fungal Skin Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Gastroenteritis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Influenza
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Kidney Infection
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Lower Respiratory Tract Infection Viral
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Lung Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
75.0%
3/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
31.2%
10/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Oral Candidiasis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Oral Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Postoperative Wound Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Sinusitis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Tooth Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Clavicle Fracture
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Limb Injury
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Injury, poisoning and procedural complications
Pelvic Fracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Alanine Aminotransferase Increased
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Aspartate Aminotransferase Increased
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Creatine Phosphokinase Increased
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Iron Decreased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Phosphorus Decreased
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Blood Pressure Increased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
C-Reactive Protein Increased
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Creatinine Renal Clearance Decreased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Electrocardiogram QT Prolonged
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Investigations
Weight Decreased
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Metabolism and nutrition disorders
Type 2 Diabetes Mellitus
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
18.8%
6/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Gouty Arthritis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Joint Contracture
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
75.0%
3/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
100.0%
3/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
46.9%
15/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of Jaw
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Pain in Jaw
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Dizziness
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Dizziness Postural
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Embolic Stroke
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
18.8%
6/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
75.0%
3/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
21.9%
7/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Post Herpetic Neuralgia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Tremor
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Nervous system disorders
Visual Field Defect
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Depressed Mood
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Depression
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
75.0%
3/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
8/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Psychiatric disorders
Mood Altered
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Pollakiuria
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Renal Impairment
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic Bronchitis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
16/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dry Throat
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
50.0%
2/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
66.7%
2/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discoloured
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
12.5%
4/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Rash Generalised
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Skin Fragility
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
3.1%
1/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
33.3%
1/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Vascular disorders
Flushing
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
6.2%
2/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Vascular disorders
Hypertension
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
25.0%
1/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
31.2%
10/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/4 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
0.00%
0/3 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
9.4%
3/32 • Deaths: From screening (Day -21) up to 5 years; Serious and Other AEs: From Day 1 up to 50.4 months
All treated analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 1. The safety analysis set included all enrolled participants who received at least one non-zero dose of any study drug during Phase 2.
|
Additional Information
Senior Director, Clinical Research
Janssen Research & Development, LLC
Phone: 844-434-4210
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If an investigator wishes to publish information from the study, a copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested by the sponsor in writing, the investigator will withhold such publication for up to an additional 60 days.
- Publication restrictions are in place
Restriction type: OTHER